Regulatory

December 1, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 20 Nov)
Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle. MHRA fees* Page summary: Fees payable to the MHRA for 2023…
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December 1, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 20 Nov)
Please note this is an extract of the original bulletin. Biggest prostate cancer screening trial in decades to start in UK Page summary: The trial will use innovative screening methods like an MRI scan and see hundreds of thousands of men across the country participating Change made: First published. Government response to the review into commercial clinical trials Page summary:…
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December 1, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 20 Nov)
Please note this is an extract of the original bulletin. Smarter regulation Page summary: This page sets out how the UK government’s smarter regulation programme seeks to reduce burdens on businesses and promote innovation and growth. Change made: Retained EU employment law reforms added to the page under the “Policy Decisions” section. Notice to exporters 2023/22: Export Control Joint Unit…
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December 1, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 20 Nov)
Please note this is an extract of the original bulletin. Consistency in household and business recycling in England Page summary: Seeking views on our plans to increase the consistency in materials collected for recycling in England. Change made: Further to the update of 25 October 2023, no further errors were found within the ‘Summary of consultation responses’ report. The Executive…
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December 1, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 20 Nov)
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated lists of professionals who can certify export health certificates. Export lab…
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December 1, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 20 Nov)
Please note this is an extract of the original bulletin. Regulations: ecodesign of energy-consuming products Page summary: Guidance for manufacturers, their authorised representatives and importers. Change made: List in ‘What is covered’ section updated. OPSS enforcement: enforcement actions Page summary: Guidance for businesses we regulate on enforcement actions and associated rights. Change made: Separate new guides published for the alternative…
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December 1, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 20 Nov)
Please note this is an extract of the original bulletin. Towards a sustainable, multilateral, and universal solution for international data transfers Page summary: Expert analysis of the challenges to a sustainable and scalable approach to international data transfers and proposed solutions. Change made: First published. Landmark sci-tech deal with the Republic of Korea to boost cooperation in critical technologies such…
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December 1, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC weekly update (WC 20 Nov)
Please note this is an extract of the original bulletin. Get a goods movement reference: check service availability and issues Page summary: Check the availability and any issues affecting the get a goods movement reference service. Change made: Planned downtime from 10pm on Saturday 9 December 2023 to 5am Sunday 10 December 2023 has been added. Search the register of…
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December 1, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 20 Nov)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 23 November These include updates on news, including regulatory updates, transitional guidance and events.
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December 1, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Updated Producer Responsibility Obligations for England and Wales
The Producer Responsibility Obligations (Packaging Waste) (Amendment) (England and Wales) Regulations 2023 amends the Producer Responsibility Obligations (Packaging Waste) Regulations 2007 which sets annual business targets for the recycling of packaging waste and apply to all businesses that produce or use packaging. These Regulations impose on producers obligations to recycle packaging waste in order to attain overall recycling and material-specific recycling…
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November 24, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
MedTech Europe RAC
This week, BIVDA was represented at MedTech Europe Regulatory Affairs Committee (RAC) by Stuart and Tehelj. The meeting was also attended by members of the European Commission. It was a constructive meeting with a focus on the published paper on the Future of Europe's Medical Technology Regulation, and the continued challenges on the transition to the EU IVD Regulation.
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November 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 13 Nov)
Please note this is an extract of the original bulletin. Designated standards: PPE Page summary: Notices of publication and a consolidated list for designated standards for personal protective equipment (PPE). Change made: Scheduled notice of publication postponed. Designated standards: machinery Page summary: Notices of publication and a consolidated list for designated standards for machinery. Change made: Scheduled notice of publication…
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November 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 13 Nov)
Please note this is an extract of the original bulletin. MHRA authorises world-first gene therapy that aims to cure sickle-cell disease and transfusion-dependent β-thalassemia Page summary: Casgevy (exagamglogene autotemcel) is based on the innovative gene-editing tool CRISPR, which won its inventors the Nobel Prize in 2020 Change made: First published.
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November 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 13 Nov)
Please note this is an extract of the original bulletin. UK Innovation Strategy: leading the future by creating it Page summary: This strategy sets our ambitions for an innovation-led economy. Change made: Linked ‘National digital twin programme (NDTP)’ to its collection page. 2,500 new places on artificial intelligence and data science conversion courses now open to applicants Page summary: Government…
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November 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 13 Nov)
Please note this is an extract of the original bulletin. Reference documents for Customs (Additional Duty) (Russia and Belarus) Regulations 2022 Page summary: Find out about the additional duties which apply on certain goods originating from Russia and Belarus. Change made: Update of the Russian and Belarusian additional duties documents to version 1.4. Additional duties on goods originating in Russia…
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November 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 13 Nov)
Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to export to the EU.
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November 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 13 Nov)
Please note this is an extract of the original bulletin. Check import risk categories and related rules for animals and animal products imported from the EU to Great Britain, from 31 January 2024 Page summary: Import risk categories under the Border Target Operating Model (BTOM) for animals or animal products you’re importing from the EU, Switzerland, Norway, Iceland and Liechtenstein…
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November 24, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive
BSI webinar on EU IVDR regulatory updates
BSI are hosting a webinar about the latest IVDR regulatory updates on 28 November. The webinar will include a short recap on where the IVDR is, along with latest MDCG guidance and developments in Brussels; description of the challenges for Class D IVD’s and the status on EU Reference Labs and envision the potential ramifications for manufacturers of these updates.…
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November 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA update on Modulated Fees
DEFRA have provided the following information on future assessment criteria for Modulating Fees and the packaging information needs of all parties involved in the end-to-end production of goods: Over 100 people from a wide range of interest groups took part in a Modulated Fees visioning event held on 24 October 2023, including representatives from the Welsh Government, trade associations, North…
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November 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. Access Consortium Page summary: The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic. Change made: Added details of the Access Consortium’s Advanced Therapy Medicinal Products Working Group. Medical devices given exceptional use authorisations during the COVID-19…
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November 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. Biomanufacturing Fund (BMF): phase 2 open to expressions of interest Page summary: This fund is to support commercial-scale vaccines and biotherapeutics manufacturing projects that will improve the UK’s health resilience for future pandemics. Change made: Deadline to submit a Expression of Interest (EOI) form changed to 12pm (midday) on Friday…
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November 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. Export processed animal protein and rendered fat from non-ruminant animals to Malaysia: certificate 8748 updated Page summary: Apply online to export processed animal protein (PAP) and rendered fat from non-ruminant animals that is not intended for human consumption to Malaysia Change made: Updated NFG Apply for an export health certificate…
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November 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. UK REACH: alternative transitional registration model (ATRm) Page summary: Outlines our plans for an alternative transitional registration model (ATRm) for UK REACH. Change made: First published. Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved…
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November 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. Weights and measures: national and EEC stamp numbers Page summary: Listings of numbers for identifying items of weighing or measuring equipment. Change made: List of authorised stamp numbers updated. Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards for businesses. Change made:…
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November 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. UK Statement at 7th Intergovernmental Negotiating Body Page summary: UK opening intervention at the 7th Intergovernmental Negotiating Body. Delivered by the UK’s Ambassador to the WTO and UN, Simon Manley, on 6 November 2023. Change made: First published.
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November 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The list of customs agents has been updated with two additions. Customs, VAT and excise UK transition legislation from 1…
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November 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 13 Nov)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 16 November These include updates on news, including regulatory updates, transitional guidance and events.
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November 17, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
TGA webinar on Australian UDI implementation
The TGA is in the process of establishing the Australian Unique Device Identification Database (AusUDID). The TGA is hosting a webinar to provide an update on the Australian UDI implementation and a presentation on learnings and the real-world benefits of the UDI adoption in the US healthcare system. The webinar is held on 21 November from 11:30am to 12:30pm (AEDT).…
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November 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. Mandatory digital customs requirements: parcels to Ireland Page summary: This guidance is for businesses looking to send parcels to Ireland from the UK using Royal Mail, Parcel Force and the UK’s nationwide network of Post Offices. Change made: First published. Government slashes up to £1bn a year of business burdens…
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November 17, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Preparations for Revisions to ISO 13485 – User survey
In follow up to the plenary discussions in December 2022, ISO/TC 210 (AAMI QM, Quality management and corresponding general aspects for products with a health purpose including medical devices) Working Group has begun preparatory work on items for future revision of ISO 13485:2016. The technical committee have launched a survey seeking feedback on the use of the standard for regulatory…
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November 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations
MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…
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November 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
EPSCO meeting to be held on 30 Nov
Employment, Social Policy, Health and Consumer Affairs Council (EPSCO) is the meeting of the EU Ministers of Health. The upcoming EPSCO meeting agenda includes the implementation of IVDR and MDR with information from the French delegation, supported by the Belgian, German, Irish and Italian delegations. EPSCO is the meeting of the EU Ministers of Health. A public debate is proposed.…
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November 10, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. Export animal materials for medical, pharmaceutical and cosmetic use to the USA: certificate 6038 updated Page summary: Apply online to export animal derived materials for medical, pharmaceutical and cosmetic use to the USA. Change made: Updated NFG Export processed animal protein (PAP) from ruminants, or both ruminants and non-ruminants, to…
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November 10, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. The Innovative Devices Access Pathway (IDAP) Page summary: The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market. Change made: Applications for the Innovative Devices Access Programme (IDAP) pilot now closes 1 November 2023 and…
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November 10, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. New £100 million fund to capitalise on AI’s game-changing potential in life sciences and healthcare Page summary: A new mission announced by the Prime Minister will accelerate the use of AI in life sciences to tackle the biggest health challenges of our generation. Change made: First published. AI to speed…
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November 10, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. Philanthropic partnership unlocks £32 million for the future of best-in-class UK Biobank Page summary: Eric Schmidt and Ken Griffin are being announced as the first members of a new consortium that will shape the future of the best-in-class UK Biobank. Change made: First published. Association of Southeast Asian Nations (ASEAN):…
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November 10, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. Report payments and view your allowance for non-customs state aid and customs duty waiver claims Page summary: Use the online service to report non-customs state aid payments you’ve received to HMRC and view your state aid allowance if you’ve claimed customs duty waivers. Change made: Information on reporting for non-customs…
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November 10, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
Swissmedic weekly update (WC 06 Nov)
Please note this is an extract of the original bulletin. New information on submitting vigilance reports for medical devices Swissmedic has revised the information on submitting vigilance reports (incidents, trend reports and FSCA reports) for products according to the Medical Devices Ordinance (SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (SR 812.219)
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November 10, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. OPSS enforcement: enforcement policy Page summary: Guidance for businesses we regulate. Change made: Draft version of revised Enforcement Policy published for consideration, with any feedback requested by 15 December 2023. Simple Pressure Vessels (Safety) Regulations 2016 Page summary: Guidance for businesses. Change made: Minor changes to the NI guide to…
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November 10, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
MedTech Europe position paper published: The Future of Europe’s Medical Technology Regulations
MedTech Europe have published a position paper The Future of Europe’s Medical Technology Regulations. This paper describes MedTech Europe’s vision for an efficient, innovation-focused, and well-governed regulatory framework. It addresses healthcare access challenges resulting from the structural issues of the European regulatory system. MedTech Europe has called out for comprehensive reform addressing the three key areas of efficiency, innovation and…
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November 10, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. Environmental principles duty comes into force Page summary: Under the duty set out in the Environment Act 2021, ministers and policy makers must consider the environmental impact of new policies. Change made: First published. Assessing environmental impact Page summary: Guidance for policy officials in government to identify and assess the…
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November 10, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. Industry Minister makes historic visit to Mongolia to boost UK critical minerals supply chains Page summary: Industry Minister Nusrat Ghani is in Mongolia in an historic visit to boost the UK’s critical minerals supply chains. Change made: First published. Smarter regulation Page summary: This page sets out how the UK…
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November 10, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 06 Nov)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 08 November These include updates on news, including regulatory updates, transitional guidance and events.
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November 3, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
Swissmedic weekly update (WC 30 Oct)
Obligations for authorised representatives, importers and distributors The Medical Devices Ordinance (MedDO; SR 812.213) and the Ordinance on In Vitro Diagnostic Medical Devices (IvDO; SR 812.219) set out requirements and responsibilities for operators in the medical devices supply chain. The following Information sheet outlines the roles and obligations of the Swiss authorised representative, the importer and the distributor. It also…
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November 3, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
Sertio Oy designated as EU Notified Body
Sertio Oy from Finland is designated as a notified body under the Regulation on In vitro Diagnostic Medical Devices (2017/746, IVDR). To date, there are twelve notified bodies designated under the EU IVDR. This designation was published on NANDO database on 31 October September 2023. This can be considered as significant news to the European diagnostics industry.
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November 3, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 30 Oct)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 02 November OLS Borders Bulletin - 31 October These include updates on news, including regulatory updates, transitional guidance and events.
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November 3, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA to launch the AI-Airlock, a new regulatory sandbox for AI developers
The MHRA is to launch a regulatory sandbox- AI-Airlock to support the development of AI services in improving diagnoses, treatment selections and providing enhanced personalised care for patients. This regulatory sandbox aims to accelerate the development and deployment of software and AI medical devices, safely providing patients with earlier access to cutting edge innovations that improve care. The AI-Airlock will be…
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November 3, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 23 Oct)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 26 October These include updates on news, including regulatory updates, transitional guidance and events.
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November 3, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive
U.S. FDA weekly update (WC 30 Oct)
FDA Establishes New Advisory Committee on Digital Health Technologies The US FDA have formed a new Advisory Committee on Digital Health Technologies (DHTs) to help address different issues related to DHTs such as artificial intelligence/machine learning (AI/ML), augmented reality, virtual reality, digital therapeutics, wearables, remote patient monitoring and software. The committee will also advise the FDA on these issues, providing…
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November 3, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 23 Oct)
Please note this is an extract of the original bulletin. Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles Page summary: Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes. Change made: First published. MHRA and international partners publish five guiding principles for machine learning-enabled medical devices Page summary: The Medicines…
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November 3, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 23 Oct)
Please note this is an extract of the original bulletin. Smarter regulation and the regulatory landscape Page summary: Call for evidence on what works and what could be improved across the landscape of UK regulators. Change made: Link to response form also added under ‘How to respond’ in the call for evidence overview document. UK-Japan Critical Minerals Memorandum of Cooperation…
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November 3, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 23 Oct)
Please note this is an extract of the original bulletin. Export processed animal protein from ruminant animals or a combination of ruminant and non ruminant animals to Malaysia: certificate 8141 updated Page summary: Apply online to export processed animal protein (PAP) derived from either ruminants or from both ruminants and non-ruminants, excluding finished pet food, compound feeds, feed premixes, feed…
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November 3, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 23 Oct)
Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Updated import requirements for exporting live ruminants from bluetongue virus serotype 3 (BTV-3) affected countries to Great Britain. Also removed Switzerland from…
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November 3, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Gov.uk policy papers update (WC 23 Oct)
Please note this is an extract of the original bulletin. Consistency in household and business recycling in England Page summary: Seeking views on our plans to increase the consistency in materials collected for recycling in England. Change made: We have uploaded a new version of the Summary of consultation responses report (PDF). An earlier version of this report incorrectly stated…
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November 3, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 23 Oct)
Please note this is an extract of the original bulletin. Expert regional innovation hubs given £75 million boost to local research, businesses and economies across UK Page summary: Regional clusters of innovation across the UK backed by £75 million that will boost local economies and pioneer game-changing solutions from healthcare to net zero. Change made: First published. Research Ventures Catalyst…
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November 3, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 30 Oct)
Please note this is an extract of the original bulletin. Government responses to the Committee on Climate Change (CCC) annual progress reports Page summary: Government responses to the Committee on Climate Change (CCC) annual progress reports. Change made: Added Committee on Climate Change 2023 progress report: government response.
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October 27, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
TEAM-NB Notified Bodies call to action to manufacturers to apply
Team-NB hve published a press release "TEAM-NB Notified Bodies call to action to manufacturers to apply. October 2023" This press release is a call to action to to apply with notified bodies in time especially for high-risk IVD medical devices. It intends to raise awareness with the device manufacturers and other economic operators to apply with notified bodies in time.…
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October 27, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA and international partners publish guiding principles for machine learning-enabled medical devices
MHRA, U.S. Food and Drug Administration (FDA) and Health Canada have jointly released 'Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles' In this document, MHRA, FDA and Health Canada have jointly identified 5 guiding principles for predetermined change control plans (PCCP). These principles draw upon the Good Machine Learning Practice (GMLP) guiding principles. PCCPs provide a new…
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October 27, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 09 Oct)
Please note this is an extract of the original bulletin. Government launches review of regulators to cut red tape and bureaucracy Page summary: Review set up to cut burdens for businesses in new post-Brexit regulatory framework and improve customer outcomes Change made: First published. Smarter regulation Page summary: This page sets out how the UK government’s smarter regulation programme…
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October 27, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 02 Oct)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 05 October These include updates on news, including regulatory updates, transitional guidance and events.
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October 27, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
NICE’s support offer: Survey
NICE is currently reviewing its support offer for life science companies. They invite your views on the types of knowledge and format of delivery you would find useful to receive from them. The survey link can be found complete this here.
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October 27, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
TGA medical devices vigilance program pilot
The TGA is commencing a 12-month pilot of the new Medical Devices Vigilance Program. Sponsors who have medical devices included in the Australian Register of Therapeutic Goods can volunteer for the pilot. The pilot is designed to support medical device sponsors comply with regulation and give the public confidence that sponsors are meeting their responsibilities. More information on this program…
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October 27, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 09 Oct)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 12 October These include updates on news, including regulatory updates, transitional guidance and events.
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October 27, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 09 Oct)
Please note this is an extract of the original bulletin. Export of non-ruminant processed animal proteins and rendered fats not intended for human consumption to Chile: certificate 8713 updated Page summary: Apply online to export non-ruminant poultry, porcine and equine PAPs derived from protein, including pure or mixed viscera meals, meat and bone meal, feathermeal and oils or fats to…
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October 27, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 09 Oct)
Please note this is an extract of the original bulletin. Government to invest £30 million in innovative technology for NHS* Page summary: Applications are now open for Integrated care systems to apply for a share of £30 million to roll out innovative technology Change made: The press release has been updated as applications are now open for ICSs to bid…
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October 27, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 16 Oct)
Please note this is an extract of the original bulletin. Weights and measures: national and EEC stamp numbers Page summary: Listings of numbers for identifying items of weighing or measuring equipment. Change made: List of authorised stamp numbers updated. Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards for businesses. Change made:…
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October 27, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 16 Oct)
Please note this is an extract of the original bulletin. New innovation challenge launched to tackle bias in AI systems Page summary: UK companies can apply for up to £400,000 in government investment to fund innovative new solutions which tackle bias and discrimination in AI systems. Change made: First published. DSIT cyber security newsletter – October 2023 Page summary: The…
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October 27, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 16 Oct)
Please note this is an extract of the original bulletin. Burdensome legislation withdrawn in latest move to cut red tape for businesses Page summary: The Government has withdrawn draft regulations after consultation with companies raised concerns about imposing additional reporting requirements. Change made: First published. New transparency over resilience and assurance for big business Page summary: A factual overview of…
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October 27, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 16 Oct)
Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Updated guidance for imports of live ruminants from countries with bluetongue virus serotype 3 (BTV-3). Added outbreak of epizootic haemorrhagic disease (EHC)…
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October 27, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 16 Oct)
Please note this is an extract of the original bulletin. Packaging data: how to create your file for extended producer responsibility Page summary: How to structure your packaging data submission. It includes information about the different types of data you need to submit and the codes you need to use. Change made: We’ve added a link so that you can…
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October 27, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 16 Oct)
Please note this is an extract of the original bulletin. Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The list of customs agents has been updated with one addition and one amendment. The Retained EU Law (Revocation and…
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October 27, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Gov.uk policy papers update (WC 16 Oct)
Please note this is an extract of the original bulletin. Wet wipes containing plastic: proposed ban on the manufacture, supply and sale Page summary: The UK Government, Welsh Government, Scottish Government and the Department of Agriculture, Environment and Rural Affairs for Northern Ireland want your view on a proposed ban on the manufacture, supply and sale of wet wipes containing…
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October 27, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive
U.S. FDA weekly update (WC 23 Oct)
Webinar - Proposed Rule: Medical Devices; Laboratory Developed Tests On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be covered under the requirements of Food, Drug and…
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October 20, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Department for Science, Innovation and Technology
Code of practice for app store operators and app developers Page summary: This code of practice sets out minimum security and privacy requirements for app store operators and app developers. Change made: An updated version of the Code of Practice has been added to this page. This is the latest version.
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October 20, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Department for Business and Trade
UK to host Minerals Security Partnership for first time to boost investment in critical minerals Page summary: On Tuesday 10 October, the UK hosted the Principals’ meeting of the Minerals Security Partnership for the first time, at the London Metals Exchange. Change made: First published. Time updated: 2:09pm, 11 October 2023 Placing manufactured products on the market in Great…
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October 20, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Brexit
Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The customs agents list has been updated with one addition, one amendment and one removal.
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October 20, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Animal and Plant Health Agency
Export of non-ruminant processed animal proteins and rendered fats not intended for human consumption to Chile: certificate 8713 updated Page summary: Apply online to export non-ruminant poultry, porcine and equine PAPs derived from protein, including pure or mixed viscera meals, meat and bone meal, feathermeal and oils or fats to Chile not intended for human consumption. Change made: Guidance notes…
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October 20, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Department for Environment, Food & Rural Affairs
Import risk categories for animals and animal products imported from the EU to Great Britain, from 31 January 2024 Page summary: Import risk categories under the Border Target Operating Model (TOM) for animals or animal products you’re importing from the EU to Great Britain (England, Scotland and Wales), and the import rules for each category. Change made: We’ve updated the…
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October 13, 2023 in European Commission Updates Environmental Newsletter Archive, European Commission Updates Regulatory Affairs Newsletter, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive
HSE CLP ebulletin: ECHA public consultations: call for comments
HSE CLP ebulletin: ECHA public consultations: call for comments (govdelivery.com)
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October 13, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Department for Business and Trade
Note: The comment under UKCA marking (excluding medical devices etc.) that if UK Designated standards have restrictions that aren’t included in the EU Harmonised standards, then designated standards take precedent, even though they’re not recognised for CE conformity assessment. See sector guidance for further details. This means that although CE marked goods are recognised for the GB market, Manufacturers/Importers…
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October 13, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Department for Environment, Food & Rural Affairs
Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to export to the EU. Accredited Trusted Trader Scheme pilot Page summary: How to…
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October 13, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Department for Science, Innovation and Technology
New £60 million Regional Innovation Fund among measures to boost research and development Page summary: A £60 million Regional Innovation Fund (RIF) that will boost support for universities in areas with lower levels of R&D investment is among new measures Technology Secretary Michelle Donelan has announced.
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October 13, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
Share Your Expertise
CLSI Volunteer Opportunities for Standards Development
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October 13, 2023 in Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter
Weekly update from GOV.UK for: Brexit
Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The customs agents list has been updated with one amendment and one addition. Time updated: 1:38pm, 3 October 2023 Safety and security requirements on imports and exports Page summary: Find…
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October 13, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Weekly update from GOV.UK for: Animal and Plant Health Agency
Animal diseases: international and UK monitoring Page summary: Monitoring for major, notifiable or new and emerging animal disease outbreaks internationally and in the UK. C Imports, exports and EU trade of animals and animal products: topical issues
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October 13, 2023 in Industry newsletters Environmental Newsletter, Industry Newsletters Environmental Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
IFCC eNews
IFCC eNews – IFCCeNewsOct2023.pdf (pub-180a8d00f517477ba49634e6b2b147e3.r2.dev) There are a number of free webinars including one on ‘The clinical Laboratory and its impact on the environment’ and an update on the IFCC Scientific Division ( Scientific Division - IFCC ). One of the tasks of the IFCC Scientific Division is to develop reference methods for medical laboratory assays.
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October 13, 2023 in Other Updates Environmental Newsletter, Other Updates Environmental Newsletter Archive, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, Regulatory Newsletter Environmental, Regulatory Newsletter Regulatory
California Governor Signs Climate Disclosure Bills, but Pushes Back on Timeline and Cost
California Governor Signs Climate Disclosure Bills, but Pushes Back on Timeline and Cost - ESG Today ESG REPORTING/ GOVERNMENT California Governor Signs Climate Disclosure Bills, but Pushes Back on Timeline and Cost Mark Segal October 9, 2023 California Governor Gavin Newsom signed two new landmark climate-related disclosure bills on Saturday, which will require large companies to disclose their value chain emissions…
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October 13, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 02 Oct)
Please note this is an extract of the original bulletin. Approved manufacturers: conformity assessment Page summary: Apply to become or identify an approved manufacturer authorised to carry out conformity assessment. Weights and measures: national and EEC stamp numbers Page summary: Listings of numbers for identifying items of weighing or measuring equipment.
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October 13, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 02 Oct)
Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Updated information on epizootic haemorrhagic disease (EHD) in Europe.
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October 13, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 02 Oct)
Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: The 'COVID-19 test validation approved products' file has been updated. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: The webinar recording has been…
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October 6, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive
U.S. FDA weekly update (WC 25 Sept)
FDA Proposes Rule Aimed at Helping to Ensure Safety and Effectiveness of Laboratory Developed Tests | FDA On September 29, the U.S. Food and Drug Administration (FDA) announced a proposed rule which aims to end enforcement discretion on Laboratory Device Tests (LDTs). This means, under this proposed rule, that LDTs will be regulated a medical device and it will be…
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October 6, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 25 Sept)
Please note this is an extract of the original bulletin. Designated standards Page summary: Lists of standards that businesses can use to show their products, services or processes comply with essential requirements of legislation. Change made: Text added to clarify the purposes of informative notes. Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists…
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October 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 25 Sept)
Please note this is an extract of the original bulletin. AI Safety Summit: introduction Page summary: Introduction to the AI Safety Summit 2023 that will take place on the 1 and 2 November at Bletchley Park, Buckinghamshire. Change made: First published.
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October 6, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 25 Sept)
Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated 3 of the lists of businesses approved to export to…
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October 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 25 Sept)
Please note this is an extract of the original bulletin. The Northern Ireland MHRA Authorised Route (NIMAR)* Page summary: The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022. Change made: Information added about transitional arrangements for licences associated with the implementation of the Windsor Framework and links…
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October 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 25 Sept)
Please note this is an extract of the original bulletin. UK signs sixth US state deal with Washington State Page summary: The UK and the US state of Washington will today sign a new Memorandum of Understanding (MoU) to boost trade and investment. Change made: First published. Notices to exporters Page summary: Notices to exporters published by the Export Control…
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October 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 25 Sept)
Please note this is an extract of the original bulletin. Smarter regulation Page summary: This page sets out how the UK government’s smarter regulation programme seeks to reduce burdens on businesses and promote innovation and growth. Change made: New section added for ‘Calls for evidence’. ‘Package travel legislation: updating the framework’ and ‘Smarter regulation non-financial reporting review: call for evidence’links…
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October 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
gov.uk policy papers update (WC 25 Sept)
Please note this is an extract of the original bulletin. Charging arrangements at government-run border control posts Page summary: This consultation seeks views on the government’s plan to introduce a Common User Charge to recover operating costs at government-run border control posts. Change made: Added information about the number of responses received. UK mandatory water efficiency labelling Page summary: Seeking…
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October 6, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 25 Sept)
Please note this is an extract of the original bulletin. APHA laboratory test submissions and price lists Page summary: Guidance on the Animal and Plant Health Agency laboratory testing services and prices for animal disease diagnosis. Change made: Updated the price for the fast track service to £75.30. Balai Directive: approved premises Page summary: Institutes, centres and premises in Great…
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October 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 25 Sept)
Please note this is an extract of the original bulletin. Women’s health hubs £25 million transformation fund Page summary: Information on allocation and delivery of the £25 million women’s health hubs transformation fund. Change made: Women’s health hubs reporting template updated because one of the drop-down menus was previously incorrect.
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September 29, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 18 Sept)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 20 September These include updates on news, including regulatory updates, transitional guidance and events.
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September 29, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive
U.S. FDA weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. CDRH Issues Updated Final Guidance on the Breakthrough Devices Program The U.S. Food and Drug Administration (FDA) issued an update to the final guidance: Breakthrough Devices Program. The updates align with the actions outlined in the FDA’s Center for Devices and Radiological Health (CDRH) Strategic Priorities to Advance Health Equity…
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September 29, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. Business regulation: statutory review requirements Page summary: Guidance for departments on what they need to consider when deciding whether a review provision is appropriate. Change made: Added new statutory guidance. Smarter regulation Page summary: This page sets out how the UK government’s smarter regulation programme seeks to reduce burdens on…
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September 29, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. Packaging data: what to collect for extended producer responsibility Page summary: A guide to collecting data about your packaging. This is for UK organisations affected by extended producer responsibility (EPR) for packaging. Change made: An update to match regulations: where packaging is described as ‘imported, emptied and then discarded’, that’s…
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September 29, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. Export animal derived peptones to Canada: certificate 8806 Page summary: Apply online to export animal derived peptones to Canada. Change made: First published. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products…
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September 29, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. Search the register of customs agents and fast parcel operators Page summary: Find a customs agent or fast parcel operator to help you with import and export declarations. Change made: The list of customs agents has been updated with one amendment.
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September 29, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. The Innovative Devices Access Pathway (IDAP) Page summary: The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market. Change made: First published. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List…
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September 29, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. The disclosure of industry payments to the healthcare sector Page summary: This consultation aims to seek views on the possible introduction of regulations mandating the disclosure of industry payments to the healthcare sector. Change made: Updated table 1 to clarify that there are only some payment reporting requirements and retention…
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September 29, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. Section 70: Weights and Measures returns and reports Page summary: Local Weights and Measures Authority reports and returns on enforcement work over a 12 month period. Change made: Report and local authority returns added for 2022 to 2023. Weights and Measures report published Page summary: OPSS publishes the 2022-23 Section…
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September 29, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 18 Sept)
Please note this is an extract of the original bulletin. New advisory service to help businesses launch AI and digital innovations Page summary: Businesses across the UK will have the opportunity to showcase that their new AI and digital innovations comply with regulatory standards, so they can quickly bring them to market. Change made: First published.
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September 29, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 25 Sept)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 27 September These include updates on news, including regulatory updates, transitional guidance and events.
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September 22, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. Extended producer responsibility for packaging: who is affected and what to do Page summary: How UK organisations that supply or import packaging should comply with extended producer responsibility (EPR) for packaging. Change made: This update adds a recent decision by the English and Scottish regulators: they will take no enforcement…
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September 22, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Added entry for ‘VetCert’ under East Midlands on the list ‘England: professionals…
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September 22, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. Health Protection (Notification) Regulations 2010: proposed amendments Page summary: This consultation seeks views on proposed amendments to the Health Protection (Notification) Regulations 2010 (HPNR). Change made: The deadline for this consultation has been extended to 11.59pm on 15 November 2023.
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September 22, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. Yellow Card centre launched in Northern Ireland to strengthen patient safety Page summary: A new regional centre to promote Yellow Card reporting has been launched in Belfast today. Change made: First published.
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September 22, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. REUL (Revocation and Reform) Act 2023 statutory instruments Page summary: On this page you will find the complete list of statutory instruments (SIs) which will be laid under the REUL (Revocation and Reform) Act 2023. Change made: Added 2 statutory instruments from DfE and DSIT laid under the REUL Act…
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September 22, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. The Data Protection (Fundamental Rights and Freedoms) (Amendment) Regulations 2023 Page summary: The Statutory Instrument (SI) will amend references to ‘fundamental rights and freedoms’ in the UK’s data protection legislation. Change made: First published. High-risk but high-reward research tackling hardest-to-treat cancers receives £2m funding boost Page summary: Innovative researchers working…
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September 22, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. MoU between HSE and OPSS Page summary: Memorandum of understanding between the Health and Safety Executive and the Office for Product Safety and Standards. Change made: First published.
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September 22, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. REUL (Revocation and Reform) Act 2023 statutory instruments Page summary: On this page you will find the complete list of statutory instruments (SIs) which will be laid under the REUL (Revocation and Reform) Act 2023. Change made: Added 2 statutory instruments from DfE and DSIT laid under the REUL Act…
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September 22, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
Dutch IGJ: Appeal to manufacturers: take action to meet IVDR requirements
The Dutch Health and Youth Care Inspectorate (IGJ) plans to conduct inspections to assess whether Netherlands-based manufacturers comply with IVDR requirements on vigilance and post-market surveillance. This announcement was made following a survey they conducted involving Netherlands-based manufacturers of IVDs to understand the status of the transition to Regulation (EU) 2017/746 IVDR. A summary of the results have been published on…
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September 15, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. Retained EU law dashboard Page summary: This dashboard shows a list of retained EU laws (REUL). These are laws that the UK saved to ensure legislative continuity immediately after Brexit. Change made: This is a regular update to the retained EU law (REUL) dashboard. It includes an additional 77 pieces…
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September 15, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. Weights and measures: business guidance Page summary: Resources for business. Change made: Metrology stickers order form updated for 2024.
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September 15, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. The Fluorinated Greenhouse Gases (Amendment) Regulations 2023 Page summary: Corrects a technical error in the current regulation on fluorinated greenhouse gases. Change made: First published. Businesses approved to export to the EU Page summary: Check if your business in Great Britain or one of the Crown Dependencies is approved to…
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September 15, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. UK government sets out AI Safety Summit ambitions Page summary: The AI Safety Summit will bring together key countries, technology organisations, academia and civil society. Change made: First published. Industry and national security heavyweights to power UK’s Frontier AI Taskforce Page summary: Leading names from national security to computer science…
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September 15, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. Animal by-product operating plants: approved premises Page summary: Details of approved and registered animal by-product (ABP) operating plants in Great Britain and the Channel Islands. Change made: Updated the list of animal by-product plants in Great Britain. Find a professional to certify export health certificates Page summary: A list of…
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September 15, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive
U.S. FDA weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. FDA Issues Guidance and Requests Comments as a Part of Ongoing Efforts to Modernize the Premarket Notification Program To modernize the 510(k) Program to improve the safety of medical devices, the U.S. Food and Drug Administration (FDA) issued the following three draft guidance intended to support efforts to continue to…
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September 15, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Published updated ‘COVID-19 test validation approved products’ MHRA Corporate Plan 2023 to 2026 Page summary: This plan outlines the agency’s strategic direction over the next three years. Change made: This page now…
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September 15, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 11 Sept)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 13 September Pharma Forum Brochure - 09 September These include updates on news, including regulatory updates, transitional guidance and events.
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September 15, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. The Border Target Operating Model: August 2023 Page summary: This page contains the Border Target Operating Model, our final plans for a new approach to importing goods into Great Britain, that will be progressively introduced from the end of January 2024. Change made: Added links to risk-levels of commodities from…
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September 15, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
Swissmedic weekly update (WC 04 Sept)
Please note this is an extract of the original bulletin. SwissGMDP database Swissmedic is bringing a SwissGMDP database into operation, similar to the European Medicine Agency's (EMA) EudraGMDP database. The SwissGMDP is expected to be launched on the Swissmedic website in the last first quarter of 2024, with the exact date to be announced in the coming months.
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September 15, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
Strategic Technology Roadmap for the UK IVD Industry
CPI launched a report at an OLS-supported event in Westminster, earlier this year. This report was the result of a comprehensive set of interviews, workshops as well as broad horizon-scanning through the lens of papers and patents. The report addresses the lack of ecosystem, infrastructure, and funding for IVD companies to remain in the UK and the need for a…
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September 15, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
UK HSA weekly update (WC 11 Sept)
Please note this is an extract of the original bulletin. Point prevalence survey on HCAI, AMU and AMS in England Page summary: A national point prevalence survey on healthcare associated infections (HCAIs), antimicrobial use (AMU) and antimicrobial stewardship (AMS) in England, 2023. Change made: Added training webinar videos and Q&A session details.
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 28 Aug)
Please note this is an extract of the original bulletin. £5 million fund to tackle fatal drug deaths across the UK Page summary: 12 projects awarded a share of £5 million to reduce rates of fatal drug overdoses, as part of Vaccine Taskforce style approach to tackle health challenges. Change made: First published. Telecare analogue to digital switchover: action plan…
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 28 Aug)
Please note this is an extract of the original bulletin. Cyber resilience Page summary: Details of the government’s cyber resilience policy for businesses and organisations. Change made: Added links to new research (2023 Breaches Survey; Cyber Essentials research) and new guidance (Secure Connected Places Playbook.) The UK Product Security and Telecommunications Infrastructure (Product Security) regime Page summary: The UK’s consumer…
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 28 Aug)
Please note this is an extract of the original bulletin. List of goods imported into Great Britain from Ireland that are controlled Page summary: You’ll need to follow normal import declarations rules for controlled goods imported into Great Britain from Ireland. Change made: Added information to show arrangements for movements from Ireland and in some cases Northern Ireland and Great…
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September 8, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 28 Aug)
Please note this is an extract of the original bulletin. Risk categories for animal and animal product imports from non-EU countries to Great Britain Page summary: Import risk categories under the Border Target Operating Model (TOM) for animals or animal products you’re importing from a non-EU country to Great Britain (England, Scotland and Wales), and the import rules for each…
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 28 Aug)
Please note this is an extract of the original bulletin. The Border Target Operating Model: Draft for Feedback Page summary: This page contains the draft Border Target Operating Model, published on 5 April 2023, setting out a new approach to importing into Great Britain that will be progressively introduced from the end of October 2023. Change made: Updated the details…
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September 8, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 04 Sept)
The Office for Life Sciences have published their latest updates. OLS Borders Bulletin - 01 September OLS stakeholder bulletin - 05 September These include updates on news, including regulatory updates, transitional guidance and events.
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
UK Health Security Agency weekly update (WC 28 Aug)
Please note this is an extract of the original bulletin. How to become a private provider of COVID-19 testing Page summary: Guidance for prospective providers on how to be listed as a testing provider for general population testing. Change made: Added note on legislation and guidance being under review. Minimum standards for private sector providers of COVID-19 testing Page summary: Sets out the…
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September 8, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
UL Standards update
UL have revised their UL 4200A- Products Incorporating Button Batteries or Coin Cell Batteries. The scope has been updated to include: 1.1 These requirements cover household type products that incorporate or may use button batteries or coin cell batteries. 1.2 These requirements do not cover products that exclusively use zinc-air battery technologies. 1.2A These requirements do not cover toy products…
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September 8, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 21 Aug)
Please note this is an extract of the original bulletin. Working with fluorinated gas (F gas) Page summary: You must have your own qualifications to work on equipment containing F gas, even if you work for someone else. Change made: First published. Extended producer responsibility for packaging: report packaging data Page summary: Guidance for organisations who may need to report…
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September 8, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
EU MDR and EU IVDR Communication Survey
The European Commission DG Sante has launched a “MDR and IVDR Communication Survey”. The objective of this online survey is to better understand the information needs around the EU Regulations on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). It focuses on how the stakeholders are affected by the regulations. Members are encouraged to participate in this survey.…
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
The UK Trader Scheme to close on 30 September
Following the Windsor Framework agreement between the Government and the EU agreed the Windsor Framework, a new scheme, the UK Internal Market Scheme (UKIMS), for the movement of ‘not at risk’ goods into Northern Ireland is established. This scheme replaces the UK Trader Scheme (UKTS) from 30 September 2023. Organisations are encouraged that they move goods into Northern Ireland to…
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Customs Declaration Service: announcement of phased approach for exports
HMRC announced a staged approach to the deadline to move across to the Customs Declaration Service (CDS) for exports to allow businesses more time to prepare and ensure IT is thoroughly tested. Some businesses may still be able to start making export declarations through CDS by Thursday 30 November 2023. All other export declarations should be made through CDS by…
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Public consultation on disclosure of industry payments to the healthcare sector
The Department of Health and Social Care (DHSC) has launched a public consultation on disclosure of industry payments to the healthcare sector. The consultation seeks views on the possible introduction of new secondary legislation. This legislation would place a duty on manufacturers and commercial suppliers of medicines, medical devices and borderline substances to report details of the payments and other…
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September 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 28 Aug)
Please note this is an extract of the original bulletin. Three new UK Approved Bodies to certify medical devices announced by the MHRA Page summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare…
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September 1, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
Publication of the MDR and IVDR Communication Survey (deadline September)
The European Commission recently launched a “MDR and IVDR Communication Survey” as part of their “Communication campaign on MDR and IVDR(HS-p-22-19.04, 06, 07, 08, 09, 10 and 11)”. The objective of the survey is to better understand the information needs around the MDR and IVDR, how the changes in the legislation are affecting directly involved stakeholders, and what challenges stakeholders…
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September 1, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 21 Aug)
Please note this is an extract of the original bulletin. Major conditions strategy: case for change and our strategic framework Page summary: Ahead of the government’s forthcoming major conditions strategy, this report sets out our approach to tackling the groups of conditions that drive ill health in England. Change made: Inserted the text ‘The Rt Hon Steve Barclay MP, Secretary…
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September 1, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 21 Aug)
Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: COVID-19 test validation approved products spreadsheet updated. Medical devices: UK approved bodies Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made:…
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September 1, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 21 Aug)
Please note this is an extract of the original bulletin. Notice to exporters 2023/17 : a compound settlement Page summary: UK company fined in relation to the unlicensed trade of goods in breach of The Russian (Sanctions) (EU Exit) Regulations 2019. Change made: First published. Notices to exporters Page summary: Notices to exporters published by the Export Control Joint Unit…
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September 1, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 21 Aug)
Please note this is an extract of the original bulletin. Export lab animals to Denmark: certificate 9025 Page summary: Apply online to export laboratory animals to Denmark. Change made: First published. Export live frogs of the species Xenopus laevis for research purposes to Austria: certificate 9094 Page summary: Apply online to export live frogs of the species Xenopus laevis for…
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September 1, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive
U.S. FDA weekly update (WC 28 Aug)
Please note this is an extract of the original bulletin. FDA to update AccessGUDID Database and OpenFDA The U.S. Food and Drug Administration (FDA) updated the fields released in the public AccessGUDID Database to include the field for Global Medical Device Nomenclature (GMDN) Code along with the status of the GMDN Code, Active or Obsolete. These new fields are available…
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September 1, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
Brazilian regulator ANVISA amends medical device import law
On 18 August, Brazil’s medical device regulator ANVISA issued RDC No. 810/2023 to amend Article 60 of RDC No. 751/2022: Notification and Registration of Medical Devices. This amendment allows medical devices and accessories to be imported into Brazil if manufacture date precedes registration date. Brazil’s Import Manual was also updated to reflect this amendment. More information on this amendment can be found here.…
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September 1, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 28 August)
The Office for Life Sciences have published their latest updates. OLS stakeholder bulletin - 31 August These include updates on news, including regulatory updates, transitional guidance and events.
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September 1, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Dynamic list of standards applicable to IVDs, in collaboration with BSI
BIVDA have collaborated with BSI to develop a comprehensive list of relevant standards that relate to various aspects of IVD product development and manufacturing. We have worked jointly with BSI to compile this list of IVD Standards to help BIVDA members identify those standards relevant to IVD products and organisational needs. While the list aims to provide a clear and…
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August 25, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Intertek designated as a UK Approved Body
Recently MHRA announced the designation of TUV Rheinland UK Ltd and TUV SUD BABT Unlimited under the UK Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). On 24 August, their webpage was updated again to add the designation of Intertek Medical Notified Body UK Ltd for medical devices. Approved bodies are organisations which the MHRA…
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August 25, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 14 Aug)
Please note this is an extract of the original bulletin. Animal by-product operating plants: approved premises Page summary: Details of approved and registered animal by-product (ABP) operating plants in Great Britain and the Channel Islands. Change made: Added the latest approved animal by-product plants in Great Britain. Export animal byproducts for making cosmetic or healthcare products to Turkey: certificate 7585…
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August 25, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 14 Aug)
Please note this is an extract of the original bulletin. Extended producer responsibility for packaging: templates for organisation details Page summary: If you need to submit your organisation details under extended producer responsibility for packaging these CSV templates will help you to structure your data correctly. Change made: First published. Report packaging data Page summary: Sign in or create an…
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August 25, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 14 Aug)
Please note this is an extract of the original bulletin. Horizon Europe funding updated Page summary: Funding for research or innovation that’s ground breaking, improves European research standards or responds to challenges like climate change or food security. Change made: Updated department contacts and added details for devolved administrations
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August 25, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 14 Aug)
Please note this is an extract of the original bulletin. How to claim preferences under the Developing Countries Trading Scheme (DCTS) Page summary: This guidance outlines the requirements for claiming preferential tariffs under the Developing Countries Trading Scheme (DCTS). Change made: Removed importers knowledge from the list of types of proof of origin.
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August 25, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 14 Aug)
Please note this is an extract of the original bulletin. UKHSA priorities in 2023 to 2024 Page summary: Letter from Health Minister Maria Caulfield MP confirming the UK Health Security Agency’s role and priorities for the financial year 2023 to 2024. Change made: First published. £210 million to tackle deadly antimicrobial resistance Page summary: Up to £210 million of funding…
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August 25, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 14 Aug)
Please note this is an extract of the original bulletin. AI to help UK industries cut carbon emissions on path to net zero Page summary: New artificial intelligence (AI) solutions will accelerate industrial decarbonisation across the country, with nearly £4 million in government funding for green innovations. Change made: First published. Research Ventures Catalyst: open for applications Page summary: A…
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August 25, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Uncategorized
BIVDA publishes a position paper on Domestic Assurance
This week, BIVDA have published a position paper on domestic assurance routes to place IVD products on the Great Britain market. This paper presents the stance of the IVD industry in relation to domestic assurance and preferred routes to enter the British market. It highlights the considerations and recommendations to create well-structed market routes, with input provided by the BIVDA…
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August 25, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 14 Aug)
Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Published updated ‘COVID-19 test validation approved products’ data. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an…
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August 18, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA designates new UK Approved Bodies for Medical and IVD devices
The MHRA have increased their capacity to process conformity assessments for medical and IVD devices with the addition of TUV Rheinland UK Ltd and TUV SUD BABT Unlimited to their existing list of UK Approved Bodies. Approved bodies are organisations which the MHRA have designated to assess whether manufacturers and their medical devices meet the requirements set out in the UK…
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August 18, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 14 August)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 14 August OLS Border Bulletin - 11 August These include updates on news, including regulatory updates, transitional guidance and events.
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August 18, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA launches EPR – Report Packaging Data (RPD) service
DEFRA have launched EPR - Report Packaging Data (RPD) service to allow organisations to enrol and submit their EPR data for packaging. This new service is open to compliance scheme groups from 14 August and to large producers from 16 August. This can be accessed here. DEFRA have also released a spreadsheet which is available to producers if they wish to generate…
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August 18, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
Team NB publishes a position paper on new MDR transition timelines and Notified Body capacity
Team-NB have published a position paper on the new MDR transition timelines and Notified Body capacity on 10 August. This paper outlines the members' views on the amended timelines with regards to benefits for the European patients and as the continuity in the availability of essential medical devices in the European market.
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August 18, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 07 Aug)
Please note this is an extract of the original bulletin. UK Trade Tariff: duty suspensions and autonomous tariff quotas Page summary: Temporary duty suspensions and autonomous tariff quotas for importing goods into the UK. Change made: ‘Apply for new duty suspension’ section updated as the 2023 application window is now closed. Notice to exporters 2023/15: Export Control Joint Unit Summer…
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August 18, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 07 Aug)
Please note this is an extract of the original bulletin. Experts to lead AI Safety Summit preparations as new funding announced to modernise healthcare Page summary: Two leading experts appointed to spearhead preparations for UK to host AI Safety Summit as £13 million unveiled to revolutionise healthcare research. Change made: First published.
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August 18, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 07 Aug)
Please note this is an extract of the original bulletin. Extended producer responsibility for packaging: example file for packaging data Page summary: If you need to submit packaging data under extended producer responsibility for packaging this example file shows how you must structure your data. Change made: First published. Packaging data: how to create your file for extended producer responsibility…
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August 18, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 07 Aug)
Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Great Britain (England, Scotland and Wales) has recognised Belgium’s bluetongue virus disease-free status. Added guidance on imports of live ungulates from Belgium…
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August 18, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 07 Aug)
Please note this is an extract of the original bulletin. How tests and testing kits for coronavirus (COVID-19) work Page summary: The different types of tests and testing kits for COVID-19, and the specifications for manufacturers. Change made: The guidance on performing variant analysis for manufacturers of SARS-CoV-2 screening and diagnostic assays has been updated. Updated guidance documents are included…
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August 11, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 31 July)
Please note this is an extract of the original bulletin. CE marking recognition for medical devices and in vitro diagnostics Page summary: The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Change made: First published. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers…
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August 11, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 31 July)
Please note this is an extract of the original bulletin. Government boosts use of independent sector capacity to cut NHS waits Page summary: Thirteen new community diagnostic centres are opening across the country to deliver more than 742,000 additional scans, tests and checks a year Change made: First published.
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August 11, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 31 July)
Please note this is an extract of the original bulletin. UK border control posts: animal and animal product imports Page summary: Find an approved UK border control post (BCP) to check the animals, animal products or high-risk food and feed of non-animal origin in your consignment. Change made: Entry for Harwich edited to add in POA categories and update opening…
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August 11, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 31 July)
Please note this is an extract of the original bulletin. UK REACH authorisation for Abbott Laboratories Ltd., 14 July 2023 Page summary: Decision on application for authorisation under UK REACH. Change made: First published. UK REACH authorisation for IDEXX Laboratories Ltd., 14 July 2023 Page summary: Decision on application for authorisation under UK REACH. Change made: First published. Authorisation decisions:…
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August 11, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC weekly update (WC 31 July)
Please note this is an extract of the original bulletin. HMRC email updates, videos and webinars about importing and exporting Page summary: Learn about about importing and exporting goods. Change made: A video about importing parcels into Great Britain by post or courier has been added. Create a goods movement reference Page summary: Get a goods movement reference to move…
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August 11, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 31 July)
Please note this is an extract of the original bulletin. 5G Innovation Regions Page summary: A £40 million fund for local and regional authorities across the UK to establish themselves as ‘5G Innovation Regions’. Change made: First published. £40 million fund launched to unlock 5G benefits across the UK Page summary: The government has launched a £40 million fund to…
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August 11, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 31 July)
Please note this is an extract of the original bulletin. Smarter regulation: UK product safety review Page summary: We’re inviting views on the long-term approach to product safety, and how to ensure that the regulatory framework is fit for the future. Change made: First published. OPSS consults on smarter regulations in boost for business Page summary: Two new product safety…
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August 11, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 07 August)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 09 August These include updates on news, including regulatory updates, transitional guidance and events.
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August 11, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
TGA publishes new guidance on manufacturer evidence for IVD medical devices
Following the phase out of ISO 13485 certificates to support applications for new In Vitro Diagnostic (IVD) medical devices, the TGA have published a guidance that helps sponsors to transition to using another form of manufacturer evidence to ensure ongoing regulatory compliance. The new guidance can be found here.
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August 11, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 31 July)
Please note this is an extract of the original bulletin. Using the UKCA marking* Page summary: Find out if you need to use the UKCA (UK Conformity Assessed) marking on products you manufacture or handle. Change made: Updated the ‘call to action’ banner before the main body of text, to list the sectors the CE marking will continue to apply…
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August 4, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 31 July)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 31 July These include updates on news, including regulatory updates, transitional guidance and events.
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August 4, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
Proposal for new ISO Technical specification on sequencing and clinical application to infectious diseases
The BSI CH/212 IVDs group is responsible for standardization in the field of in vitro diagnostics (IVDs). They have put forward a proposal to develop a new technical specification, ISO/PWI TS 8219: Sequencing and clinical application to infectious diseases. The document covers the essential requirements for advanced sequencing procedure for detecting the microbes directly, without the need for microbial culture.…
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August 4, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 24 July)
Please note this is an extract of the original bulletin. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Guidance updated to reflect the latest information regarding the MORE portal. COVID-19 test validation approved products Page summary: Find out which…
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August 4, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 24 July)
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Dorset Council Partnership is now changed to Dorset Council, with new contact…
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August 4, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 24 July)
Please note this is an extract of the original bulletin. Extended producer responsibility for packaging: who is affected and what to do Page summary: How UK organisations that supply or import packaging should comply with extended producer responsibility (EPR) for packaging. Change made: There’s been a decision to defer extended producer responsibility for packaging fees for one year. This update…
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August 4, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 24 July)
Please note this is an extract of the original bulletin. Code on Genetic Testing and Insurance: call for evidence* Page summary: We are seeking views on the Code on Genetic Testing and Insurance, to help us decide whether it may need to be revised to ensure it remains beneficial to both consumers and the insurance industry. Change made: First published.…
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August 4, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 24 July)
Please note this is an extract of the original bulletin. Approved manufacturers: conformity assessment Page summary: Apply to become or identify an approved manufacturer authorised to carry out conformity assessment. Change made: List of approved manufacturers updated. Approved verification: guidance and application form Page summary: Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended). Change made: Register…
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August 4, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 24 July)
Please note this is an extract of the original bulletin. Joint outcome statement: UK-India round eleven FTA negotiations Page summary: Round eleven of negotiations for a free trade agreement between the United Kingdom and the Republic of India Change made: First published. Training on export control compliance Page summary: Courses, seminars, workshops and webinars to help exporters understand their obligations…
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August 4, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 24 July)
Please note this is an extract of the original bulletin. Research Ventures Catalyst: open for applications Page summary: A pilot programme that will stimulate the creation of novel research ventures, via entrepreneurial team-based approaches in collaboration with partners drawn from the public sector, industry and the third sector. Change made: Research Ventures Catalyst open for applications question and answer document…
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August 4, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive
U.S. FDA weekly update (WC 24 July)
Please note this is an extract of the original bulletin. For In Vitro Diagnostic Test Developers: Updates to the FDA’s Clinical Laboratory Improvement Amendments (CLIA) Web pages Make Processes Clearer, Easier to Understand The Clinical Laboratory Improvement Amendments (CLIA) and the associated regulations provide the authority for oversight of clinical laboratories and laboratory testing. While the Centers for Medicare and…
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August 4, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
Swissmedic weekly update (WC 24 July)
Please note this is an extract of the original bulletin. MRA between Switzerland and the USA on the manufacturing practice for medicinal products takes effect Mutual recognition in principle of inspections by Swissmedic and the FDA. The Mutual Recognition Agreement (MRA) between Switzerland and the United States in the area of Good Manufacturing Practice (GMP) for medicinal products signed in…
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August 4, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Extension of CE mark recognition in Great Britain for certain products
The UK Government have announced that recognition of the CE mark for most goods will be continued indefinitely, beyond December 2024. This applies only to the 18 regulations falling under the Department for Business and Trade (DBT), covering a range of products: toys pyrotechnics recreational craft and personal watercraft simple pressure vessels electromagnetic compatibility non-automatic weighing instruments measuring instruments measuring…
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July 28, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 17 July)
Please note this is an extract of the original bulletin. Foreign Secretary to call for international cooperation to manage the global implications of Artificial Intelligence Page summary: Foreign Secretary James Cleverly will chair first ever United Nations Security Council (UNSC) session on Artificial Intelligence (AI). Change made: Link to the Foreign Secretary’s speech at the UN Security Council added. Engineering…
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July 28, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 17 July)
Please note this is an extract of the original bulletin. Boost for women and girls as Women’s Health Strategy turns one Page summary: A year on from its Women’s Health Strategy, the government has announced a package of new measures to boost the health and wellbeing of women and girls. Change made: First published. Women's health hubs: information and guidance…
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July 28, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 17 June)
Please note this is an extract of the original bulletin. New lung cancer screening roll out to detect cancer sooner Page summary: National targeted lung cancer screening programme designed to catch cancer sooner announced Change made: First published. Health Secretary's Oral Statement on lung cancer screening Page summary: Health and Social Care Secretary Steve Barclay delivered an Oral Statement on…
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July 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 17 July)
Please note this is an extract of the original bulletin. Banned F gas for refilling equipment Page summary: Fluorinated gases (F gas) that you must not use to refill equipment. Change made: Corrected the line ‘This does not apply to military equipment or equipment designed to cool products to temperatures below –50°C.’ to include the minus symbol. Climate change adaptation…
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July 28, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 17 July)
Please note this is an extract of the original bulletin. CPTPP: investment report Page summary: Information on businesses from Comprehensive and Progressive Trans-Pacific Partnership (CPTPP) countries and their contribution to the UK economy. Change made: First published. UK signs treaty to join vast Indo-Pacific trade group as new data shows major economic benefits Page summary: Business and Trade Secretary Kemi…
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July 28, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 17 July)
Please note this is an extract of the original bulletin. In vitro diagnostic medical devices: guidance on legislation Page summary: Guidance explaining the main features of the Medical Devices Regulations 2002 (SI 2002 No 618, as amended) in relation to in vitro diagnostic medical devices Change made: In vitro diagnostic medical devices: guidance on legislation file updated. How tests and testing…
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July 28, 2023 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter
Draft post-market surveillance statutory instrument published on WTO website
The draft statutory instrument for post-market surveillance requirements under the new UKCA regime has been published on the World Trade Organisation website. The notification can be found here. The draft Medical Devices (Post-market Surveillance Requirements) (Amendment) (Great Britain) Regulations 2023 is applicable to Great Britain only. It introduces a new part, Part 4A, which defines the post-market surveillance requirements of…
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July 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA update on packaging EPR fees
DEFRA have confirmed that the Extended Producer Responsibility (EPR) for packaging fees have been deferred to one year. The one year delay is confirmed in the EPR guidance. This will apply from October 2025.
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July 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 17 July)
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated BCP council’s contact details in the list of professionals in England.…
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July 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 24 July)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 24 July These include updates on news, including regulatory updates, transitional guidance and events.
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July 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 17 July)
Please note this is an extract of the original bulletin. Approved verification: guidance and application form Page summary: Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended). Change made: Register of approved verifiers updated. OPSS enforcement actions Page summary: Enforcement actions from 1 April 2018 to 31 March 2023. Change made: OPSS enforcement actions 1 October to…
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July 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 10 July)
Please note this is an extract of the original bulletin. Borderline products: how to tell if your product is a medical device and which risk class applies Page summary: How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device. Change made: An additional section…
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July 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA guidance update: Regulation of In Vitro Diagnostic medical devices in Great Britain
The MHRA have recently updated their Guidance on the regulation of In Vitro Diagnostic medical devices in Great Britain to: Reflect the current requirement for UKCA marking (section 3.15) Add UK approved bodies and UKCA mark/marking in the Conformity assessment procedure flow charts (section 3.11) instead of using CE mark/marking and NBs The rest of this document remains the same.…
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July 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 10 July)
Please note this is an extract of the original bulletin. Notice to exporters 2023/12: The Export Control (Amendment) Regulations 2023 Page summary: The Export Control Joint Unit (ECJU) has amended the Export Control Order 2008 (“the 2008 Order”) and the retained Council Regulation (EC) No 428/2009. Change made: First published. Notices to exporters Page summary: Notices to exporters published by…
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July 21, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 10 July)
Please note this is an extract of the original bulletin. Balai Directive: approved premises Page summary: Institutes, centres and premises in Great Britain approved to move animals, semen and embryos covered by the Balai Directive. Change made: We have updated the approval dates for Chew Valley Animal Park, Dudley Zoological Gardens, Fernvalley Wildlife Centre, Folly Farm Leisure Limited, AB/17/10/005, Shepreth…
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July 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 10 July)
Please note this is an extract of the original bulletin. England Rare Diseases Action Plan 2023 Page summary: The second action plan setting out how the Department of Health and Social Care and delivery partners will implement the UK Rare Diseases Framework in England. Change made: Updated to link to the now published report on the Breaking Down Barriers focus…
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July 21, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 10 July)
Please note this is an extract of the original bulletin. UK REACH authorisation for Lonza Biologics Plc: 30 June 2023 Page summary: Decision on application for authorisation under UK REACH. Change made: First published. Authorisation decisions: UK REACH Page summary: Authorisation decisions on the time-limited use of hazardous substances of very high concern under UK REACH. Change made: We updated…
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July 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 10 July)
Please note this is an extract of the original bulletin. DSIT cyber security newsletter – July 2023 Page summary: The July 2023 edition of the monthly DSIT cyber security newsletter. Change made: First published.
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July 21, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BIVDA and MHRA bilateral meeting held on 18 July
On 18 July, BIVDA and MHRA met for our latest one-on-one meeting. The aim of these meetings is to ensure our relationship remains strong and we are able to collaborate on projects key to the IVD sector. The discussions are in addition to our usual day-to-day work with MHRA, specifically involving MHRA’s senior and executive staff. MHRA recently published their…
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July 14, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 03 July)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 10 July OLS Borders Bulletin - 07 July These include updates on news, including regulatory updates, transitional guidance and events
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July 14, 2023 in Industry newsletters Environmental Newsletter, Industry Newsletters Environmental Newsletter Archive, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
CLSI publishes EP33, 2nd Edition, Use of Delta Checks in the Medical Laboratory
CLSI has published guidelines on the use of delta checks in the medical laboratory. It details different approaches for validation of measurements for which delta checks are useful. It outlines the procedures to determine delta check limits and regulations for comparing current clinical results with previously reported outcomes for a specific patient. It also covers the steps involved in initiating…
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July 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HM Customs & Revenue weekly update (WC 03 July)
Please note this is an extract of the original bulletin. Check if you can claim a waiver for goods brought into Northern Ireland Page summary: You may be able to claim a waiver for goods brought into Northern Ireland so that you do not have to pay duty on those goods. Change made: First published. Time updated: 1:00pm, 3…
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July 14, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 03 July)
Please note this is an extract of the original bulletin. Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards for businesses. Change made: Proposals to amend added for personal protective equipment (PPE) and pressure equipment.
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July 14, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 03 July)
Please note this is an extract of the original bulletin. Import risk categories for animals and animal products imported from the EU to Great Britain, from 31 October 2023 Page summary: Import risk categories under the Border Target Operating Model (TOM) for animals or animal products you’re importing from the EU to Great Britain (England, Scotland and Wales), and the…
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July 14, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 03 July)
Please note this is an extract of the original bulletin. Antimicrobial resistance (AMR) Page summary: Information and resources on the UK’s plans to see antimicrobial resistance contained and controlled by 2040. Change made: Added updated links. Genetically modified organisms: applications, decisions and notifications Page summary: Information about releases of genetically modified organisms (GMOs) for research purposes, including lists of applications,…
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July 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 03 July)
Please note this is an extract of the original bulletin. Training on export control compliance Page summary: Courses, seminars, workshops and webinars to help exporters understand their obligations under export control legislation. Change made: Updated the information for some of the training courses to reflect that they are fully booked.
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July 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 03 July)
Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…
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July 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive
DHSC MedTech and Crown Commercial Service Energy Webinar for Suppliers
The DHSC Medical Technologies Directorate is hosting a webinar regarding energy alongside the Crown Commercial Service on Wednesday 19 July 2023 at 14:00 – 15:00 The webinar will include sessions by John Moors who has been working as the Customer Specialist Lead for Energy within the Crown Commercial Service. He will be presenting on: Energy Supply Contracts for Industry UK…
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July 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 03 July)
Please note this is an extract of the original bulletin. AI Council Page summary: An update on the AI Council. Change made: First published. DSIT cyber security newsletter Page summary: A monthly newsletter detailing the latest DSIT announcements, events and projects for people interested in the field of cyber security. Change made: We have added the June 2023 edition of…
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July 7, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
European Commission published update on EU reference labs
The European Commission has provided an update on the designation of EU reference labs. Reference labs are intended for high-risk medical devices and should be a part of the conformity assessment process. There are currently no reference labs designated for the IVDR. In July 2022, the European Commission opened applications to become a reference lab, specifically under 8 categories: Hepatitis…
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July 7, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 26 June)
Please note this is an extract of the original bulletin. Timeframe for accepting CE marked medical devices in Great Britain extended Page summary: CE marked medical devices will continue to be accepted on the Great Britain market beyond 30 June 2023 Change made: First published. Register medical devices to place on the market Page summary: How to register your medical…
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July 7, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 26 June)
Please note this is an extract of the original bulletin. Protection of Trading Interests Page summary: How UK persons’ trading interests are protected and when authorisations must be obtained to trade with countries subject to specific extraterritorial laws. Change made: First published. UK subsidy control statutory guidance Page summary: This guidance explains public authorities’ legal obligations under the UK subsidy…
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July 7, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 26 June)
Please note this is an extract of the original bulletin. Government response to the OEP report on post-implementation reviews of environmental laws Page summary: Government response to the Office for Environmental Protection’s report on post-implementation reviews of environmental laws. Change made: First published. Climate change adaptation reporting power: plans for the fourth round Page summary: Seeking views on how…
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July 7, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 26 June)
Please note this is an extract of the original bulletin. Science and tech figureheads lead government innovation charge Page summary: Startup boards meets for the first time, supporting department’s goal of making the UK a science and technology superpower by 2030. Change made: First published UK-Singapore data and tech agreements to boost trade and security Page summary: Memorandum of…
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July 7, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
EN ISO 25424 updated as a harmonised standard to the IVDR
The European Commission has published confirmation that EN ISO 25424:2019 Sterilisation of health care products – Low temperature steam and formaldehyde – Requirements for development, validation and routine control of a sterilisation process for medical devices is now harmonised to the IVDR.
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July 7, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 26 June)
Please note this is an extract of the original bulletin. Approved verification: guidance and application form Page summary: Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended). Change made: Register of approved verifiers updated. Designated standards: low voltage Page summary: Notices of publication and a consolidated list for designated standards for low voltage electrical equipment. Change…
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July 7, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Various pieces of UK legislation amended
Multiple UK legislative changes have taken place recently. Notably, these include changes to: The Persistent Organic Pollutants (Amendment) Regulations 2023 - These regulations amend Regulation (EU) 2019/1021 of the European Parliament and of the Council on persistent organic pollutants (recast) (OJ No L 169, 25.6.2019, p 45) to extend the period for which the specific exemption in Annex 1 applicable…
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July 7, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 26 June)
Please note this is an extract of the original bulletin. New lung cancer screening roll out to detect cancer sooner Page summary: National targeted lung cancer screening programme designed to catch cancer sooner announced Change made: First published. Health Secretary's Oral Statement on lung cancer screening Page summary: Health and Social Care Secretary Steve Barclay delivered an Oral Statement…
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July 7, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA update on packaging EPR guidelines
DEFRA have updated their guidance for packaging EPR to note that large organisations must create an account, starting from August 2023. A large organisation is one that: Has an annual turnover of £2 million or more. Is responsible for supplying or importing more than 50 tonnes of empty packaging or packaged goods in the UK. The EPR guidance can be…
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July 7, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 26 June)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 26 June OLS Borders Bulletin - 23 June These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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July 7, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 26 June)
Please note this is an extract of the original bulletin. Balai Directive: approved premises Page summary: Institutes, centres and premises in Great Britain approved to move animals, semen and embryos covered by the Balai Directive. Change made: Updated approval dates for Drayton Manor Zoo and Heythrop Zoological Gardens. Find a professional to certify export health certificates Page summary: A…
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June 30, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 19 June)
Please note this is an extract of the original bulletin. Approved verification: guidance and application form Page summary: Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended). Change made: Register of approved verifiers updated.
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June 30, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 19 June)
Please note this is an extract of the original bulletin. AI regulation: a pro-innovation approach Page summary: This white paper details our plans for implementing a pro-innovation approach to AI regulation. We’re seeking views through a supporting consultation. Change made: The consultation closed on 21 June 2023. Cyber Essentials scheme process evaluation Page summary: A research study investigating the…
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June 30, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 19 June)
Please note this is an extract of the original bulletin. Government continues delivering on £50 million funding pledge for motor neurone disease research Page summary: Around three-quarters of the £50 million funding pledged towards cutting edge research into motor neurone disease (MND) has now been handed out to projects across the UK, the government has announced today (Wednesday 21…
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June 30, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 19 June)
Please note this is an extract of the original bulletin. Export lagomorphs for experimentation to Spain: certificate 8639 updated Page summary: Use these forms and guidance document for the import into Spain of lagomorphs for experimentation Change made: Version 2 of EHC now available. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current…
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June 30, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 19 June)
Please note this is an extract of the original bulletin. Reference document for The Trade Preference Scheme (Developing Countries Trading Scheme) Regulations 2023 Page summary: Find the UK’s tariff rates for countries eligible for the Developing Countries Trading Scheme (DCTS) as referenced in The Trade Preference Scheme (Developing Countries Trading Scheme) Regulations 2023. Change made: First published. Developing Countries…
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June 30, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 19 June)
Please note this is an extract of the original bulletin. UK REACH authorisation for Lonza Biologics Plc: 30 May 2023 Page summary: Decision on application for authorisation under UK REACH. Change made: First published. Transitional applications for authorisation under UK REACH Page summary: Information about transitional applications for authorisation under UK REACH. Change made: Updated to show that authorisation has…
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June 30, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
New International Standards on Artificial Intelligence
CEN and CENELEC identifies and adopts two international standards on Artificial Intelligence: EN ISO/IEC 22989:2023 - Information technology - Artificial intelligence - Artificial intelligence concepts and terminology (publication date: 2023-06-28) and EN ISO/IEC 23053:2023 - Framework for Artificial Intelligence (AI) Systems Using Machine Learning (ML) (publication date: 2023-06-28). These standards describe the terminology for AI and concepts of AI system…
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June 30, 2023 in BIVDA Updates Environmental Newsletter, BIVDA Updates Environmental Newsletter Archive, BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive
Ashleigh to leave BIVDA, and Stuart Angell to join the team
It is bittersweet to let you all know that I will be leaving my role as Head of Regulatory Affairs at BIVDA, with my last working day being 25 August. I have loved my time working with the BIVDA secretariat and the BIVDA membership, and I’m sure I will cross paths with many of you again in the future!…
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June 23, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA guidance update: timelines for CE marked products
The MHRA have recently published an overview of timelines for placing CE marked IVD devices on the Great Britain market. The update focuses on the transitional arrangements for CE marked IVD devices compliant with EU IVDD and EU IVDR. For better understanding, a written guidance and an infographic of the timelines for placing CE marked IVD devices on the Great…
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June 23, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 12 June)
Please note this is an extract of the original bulletin. Charging arrangements at government-run border control posts Page summary: This consultation seeks views on the government’s plan to introduce a Common User Charge to recover operating costs at government-run border control posts. Change made: First published. Import risk categories for animals and animal products imported from the EU to Great…
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June 23, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 12 June)
Please note this is an extract of the original bulletin. UK Innovation Survey Page summary: This collection brings together all documents relating to the UK Innovation Survey (UKIS). Change made: Link added to a previously published statistic ‘Innovation activities by UK businesses in 2012-2014, 2014-2016 and 2016-2018, by NUTS2 geographic boundaries and Local Enterprise Partnership (LEP) area’. …
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June 23, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 12 June)
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated Daleside Vet Group’s information in the list for Wales and…
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June 23, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 12 June)
Please note this is an extract of the original bulletin. Research Ventures Catalyst Page summary: A pilot programme that will stimulate the creation of collaborative research ventures, supported by consortia drawn from the public sector, industry and the third sector. Change made: First published. £54 million boost to develop secure and trustworthy AI research Page summary: Secretary of State for…
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June 23, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 12 June)
Please note this is an extract of the original bulletin. Patients to benefit from new ambulance hubs and discharge lounges Page summary: The facilities will help cut urgent and emergency care waiting times for tens of thousands of patients across the country Change made: First published. Government response to the HSCC report and the Hewitt Review on integrated care…
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June 23, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 12 June)
Please note this is an extract of the original bulletin. UK Trade Tariff: duty suspensions and autonomous tariff quotas Page summary: Temporary duty suspensions and autonomous tariff quotas for importing goods into the UK. Change made: An application form and a guidance document added to the ‘Apply for a new duty suspension’ section. UK-Switzerland enhanced free trade agreement negotiations Page summary:…
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June 23, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 12 June)
Please note this is an extract of the original bulletin. Regulating medical devices in the UK Page summary: What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets. Change made: Published overview of timelines for placing CE marked IVDs on the Great Britain market Implementation of medical devices future…
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June 23, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 19 June)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 19 June OLS Borders Bulletin - 16 June These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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June 23, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
BSI receives UKAS accreditation for ISO/IEC 27001:2022
BSI has received UKAS accreditation for ISO/IEC 27001:2022. ISO/IEC 27001- Information Security Management (ISMS) assists organizations in effectively managing and protecting their information assets, so that they remain safe. All ISO/IEC 27001:2022 certificates issued by BSI can now be accredited by the United Kingdom Accreditation Service. More information on ISO/IEC 27001:2022 can be found here.
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June 23, 2023 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
New Statutory Instrument to extend market access for Medical Devices in Great Britain
The UK Parliament have published Statutory Instruments 2023 No. 627 “The Medical Devices (Amendment) (Great Britain) Regulations 2023” to amend the UK Medical Devices Regulations (MDR) 2002 (S.I. 2002/618). The purpose of the amendment is “to extend the periods for which certain medical devices that comply with EU legislation can be placed on the market in Great Britain.” This SI will…
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June 16, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 05 June)
Please note this is an extract of the original bulletin. Procurement at DBT Page summary: DBT’s purchasing arrangements and information for those looking to become a supplier or contractor. Change made: First published. The UK’s trade agreements Page summary: Find out which trade agreements the UK has signed and which the UK is negotiating. Change made: ‘Trade with Maldives: call…
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June 16, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 05 June)
Please note this is an extract of the original bulletin. Extended producer responsibility for packaging: who is affected and what to do Page summary: How UK organisations that supply or import packaging should comply with extended producer responsibility (EPR) for packaging. Change made: Added Welsh translation Packaging data: what to collect for extended producer responsibility Page summary: A guide to…
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June 16, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 05 June)
Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Reference guides and the videos ‘update devices and update products individually’ and ‘review and…
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June 16, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 05 June)
Please note this is an extract of the original bulletin. Health Infrastructure Plan: selection process for the next 8 new hospitals Page summary: The Department of Health and Social Care invited expressions of interests from mental health, community and acute NHS trusts who wished to be considered for inclusion in this next wave of the programme. Change made: Updated to…
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June 16, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
Formal stakeholder body created under the Health Technology Assessment Regulation
The Health Technology Assessment Stakeholder Network had its first meeting in Brussels on June 14th, where a formal stakeholder body under the Health Technology Assessment Regulation was created. There were representatives from stakeholder organisations and Member States in the Health Technology Assessment Coordination Group. This meeting was an opportunity to discuss the role of stakeholders in the implementation of the…
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June 16, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
EU Harmonisation of standards update
The European Commission's Directorate-General presented at the Medical Device Coordination Group (MDCG) – Subgroup meeting on Standards, held on 12 June 2023. The presentation and the meeting minutes will be published in the Register of Commission Expert Groups and Other Similar Entities, once approved by the members.
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June 16, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 05 June)
Please note this is an extract of the original bulletin. Animal by-product operating plants: approved premises Page summary: Details of approved and registered animal by-product (ABP) operating plants in Great Britain and the Channel Islands. Change made: Added the latest approved animal by-product plants in Great Britain. Export fish oil not for human consumption, used for feed material or outside…
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June 16, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC weekly update (WC 05 June)
Please note this is an extract of the original bulletin. Declaring goods you bring into Northern Ireland 'not at risk’ of moving to the EU Page summary: Find out if goods you bring into Northern Ireland can be declared ‘not at risk’ of moving to the EU and how to make a ‘not at risk’ declaration. Change made: You can…
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June 16, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 05 June)
Please note this is an extract of the original bulletin. Approved verification: guidance and application form Page summary: Weights and Measures Act 1985 and subsequent Deregulation Order 1999 (as amended). Change made: Register of approved verifiers updated.
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June 16, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 05 June)
Please note this is an extract of the original bulletin. The Alan Turing Institute: Applying argument-based assurance to AI-based digital mental health technologies Page summary: Case study from the The Alan Turing Institute. Change made: First published. British Standards Institution: EU AI Act Readiness Assessment and Algorithmic Auditing Page summary: Case study from the British Standards Institution. Change made: First…
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June 8, 2023 in Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive
Upcoming BSI Webinar: EU AI Act Explained: Navigating the new legislation with BSI
BSI are hosting a Medical Devices webinar on EU AI Act Explained: Navigating the new legislation with BSI. The EU Artificial Intelligence (AI) Act is a proposed European law on artificial intelligence the first law on AI by a major regulator. This webinar will look in detail at the EU AI Act, discussing the framework, the approach, the timeline, and the…
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June 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 29 May)
Please note this is an extract of the original bulletin. Human medicines: register of electronic export certificates Page summary: Department of Health and Social Care and MHRA register of electronic export certificates (human). Change made: Added Register of Electronic Export Certificates Issued by the MHRA (Human) – May 2023 PDF and XLS files Notify the MHRA about a clinical investigation…
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June 8, 2023 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
TGA phases out ISO 13485 certificates for IVD devices
The transition period for the TGA to accept ISO 13485 certificates as manufacturer evidence for IVD devices has ended on 26 May 2023. TGA no longer accepts these certificates to support IVD applications. More information on this can be found here.
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June 8, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Export health certification for inedible animal products
The amended UK model health certificates, which incorporates the changes published in October/December 2022, are now active and available for use. More information on this can be found here.
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June 8, 2023 in Industry newsletters Environmental Newsletter, Industry Newsletters Environmental Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
New BSI standard for international environmental management
A new standard BS EN ISO 14002-2:2023 Environmental management systems — Guidelines for using ISO 14001 to address environmental aspects and conditions within an environmental topic area — Part 2: Water has been added to the international environmental management series. This document uses the BS EN ISO 14001 framework to address issues related to water. It focuses on both how…
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June 8, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC weekly update (WC 29 May)
Please note this is an extract of the original bulletin. Transit newsletters – HMRC updates Page summary: Check for the latest updates about moving goods using transit and the New Computerised Transit System (NCTS). Change made: The new newsletter ‘May 2023 – Update on NCTS Phase 5: how to amend rejections’, explaining how the NCTS5 web portal will allow…
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June 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 29 May)
Please note this is an extract of the original bulletin. The Border Target Operating Model: Draft for Feedback Page summary: This page contains the draft Border Target Operating Model, setting out a new approach to importing into Great Britain that will be progressively introduced from the end of October 2023. Change made: Updated with next steps now engagement period…
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June 8, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 29 May)
Please note this is an extract of the original bulletin. Environment Agency consults on Drax carbon capture plans Page summary: The Environment Agency is encouraging the local community to attend community events to give their views. Change made: First published. Licensed waste facilities that accept waste F gas and ODS Page summary: A list of waste facilities that accept waste…
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June 8, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 29 May)
Please note this is an extract of the original bulletin. Designated standards: low voltage Page summary: Notices of publication and a consolidated list for designated standards for low voltage electrical equipment. Change made: Notice of publication amended and consolidated list updated. UK Market Conformity Assessment Bodies service redesign Page summary: New UKMCAB service launched with enhanced functionality and appearance following…
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June 8, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 29 May)
Please note this is an extract of the original bulletin. Designated standards: low voltage Page summary: Notices of publication and a consolidated list for designated standards for low voltage electrical equipment. Change made: Notice of publication amended and consolidated list updated.
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June 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 29 May)
Please note this is an extract of the original bulletin. UK-New Zealand FTA origin declaration Page summary: Origin declaration guidance for trade under the terms of the UK-New Zealand free trade agreement (FTA). Change made: First published. UK-New Zealand FTA: provisions for small and medium-sized enterprises (SMEs) Page summary: List of relevant provisions for SMEs in the UK-New Zealand free…
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June 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 29 May)
Please note this is an extract of the original bulletin. SaBTO virology subcommittee recommendations on KSHV infection Page summary: Recommendations to introduce universal serological screening of deceased donors for Kaposi’s sarcoma-associated herpesvirus (KSHV) infection. Change made: First published. SaBTO reports and guidance documents Page summary: Reports published by the advisory committee on the Safety of Blood, Tissues and Organs (SaBTO).…
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June 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 29 May)
Please note this is an extract of the original bulletin. Technology Secretary holds roundtable with leading AI innovators Page summary: Chloe Smith meets with a number of leading senior AI leaders at Downing Street for roundtable. Change made: First published.
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June 2, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC Supply Strategy and Continuity Team newsletter (May)
DHSC have issued the following newsletter for stakeholders: New £1 billion strategy for UK's semi-conductor sector A new 20-year plan to secure the world-leading strengths of the UK’s semiconductor industry was unveiled by the government this month. The strategy reveals plan to double down on design, research and advanced chip leadership – securing the UK’s position as a global…
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June 2, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 22 May)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 26 May OLS Borders Bulletin - 26 May These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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June 2, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive
Export Control Training Courses – New Dates Added
The Department of Business and Trade are hosting Export Control training to help exporting and trading individuals understand their obligations under export control legislation. New dates have been added to this training course. More information and registration can be found on Export Control Joint Unit Training Web Page. Details on annual Symposium to be held in November this year can be…
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June 2, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 22 May)
Please note this is an extract of the original bulletin. Global Centre on Biodiversity for Climate Page summary: The Global Centre on Biodiversity for Climate (GCBC) is an international research and development programme. It funds research into natural solutions for climate change and poverty. Change made: First published. Packaging data: tell us how you collected it for extended producer responsibility…
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June 2, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 22 May)
Please note this is an extract of the original bulletin. £39 million for AMR research as UK launches Global Health Framework Page summary: UK government announces up to £39 million cash injection for antimicrobial resistance (AMR) research through the Global AMR Innovation Fund (GAMRIF). Change made: First published. Global Health Framework: working together towards a healthier world Page summary: This…
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June 2, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 22 May)
Please note this is an extract of the original bulletin. UK trade agreements in effect Page summary: Find out about trade agreements that can be used now. Change made: Updated values for total UK trade with each country and bloc. Notice to Exporters 2023/08: Russia sanctions – Trade sanctions circumvention Page summary: This notice to exporters is a guidance note…
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June 2, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 22 May)
Please note this is an extract of the original bulletin. Import risk categories for animals and animal products imported from the EU to Great Britain, from 31 October 2023 Page summary: Import risk categories under the Border Target Operating Model (TOM) for animals or animal products you’re importing from the EU to Great Britain (England, Scotland and Wales), and the…
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June 2, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 22 May)
Please note this is an extract of the original bulletin. Biomanufacturing Fund Page summary: This fund is to support commercial-scale vaccines and biotherapeutics manufacturing projects that will improve the UK’s health resilience for future pandemics. Change made: First published. Commercial clinical trials in the UK: the Lord O’Shaughnessy review Page summary: Final report of the independent review of UK commercial…
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June 2, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 22 May)
Please note this is an extract of the original bulletin. Empowering SMEs in International Trade programme Page summary: Support for new and experienced exporters and importers, to help them trade internationally more confidently, successfully, and compliantly. Change made: First published. Net Zero Innovation Portfolio Page summary: The Net Zero Innovation Portfolio provides funding for low-carbon technologies and systems. Decreasing the…
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May 26, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Deadline 30 June: UK consultation on polychlorinated biphenyls (PCBs) regulations
DEFRA has opened a consultation on a draft of a statutory instrument that will amend the PCBs Regulations. Due to the organisational-specific nature of questions, members are encouraged to respond directly if they think they will be impact proposed changes to the polychlorinated biphenyls (PCBs) regulations. This consultation is open until 30 June.
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May 26, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
CEN adopts ISO 17043 as European standard
CEN have formally adopted ISO 17043: Conformity assessment — General requirements for proficiency testing as a European standard. This may impact EQA providers providing proficiency testing services such as end user POCT schemes for staff proficiency.
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May 26, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 22 May)
The Office for Life Sciences have published their latest updates. OLS Bulletin- 22 May These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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May 26, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
IBMS releases a new POCT guidance
The IBMS, in collaboration with the Royal College of Pathologists (RCPath) and the Association for Clinical Biochemistry and Laboratory Medicine (ACB), has jointly produced a new national guidance on Point of Care Testing. Members are encouraged to review this guidance.
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 22 May)
Please note this is an extract of the original bulletin. COVID-19 test approval: how to apply Page summary: How test manufacturers or distributors can apply for approval of their tests to sell on the UK market. Change made: Updated notice on change to the application process. Global AI challenge to investigate veterans’ cardiovascular health launched Page summary: A brand-new challenge…
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Submitting Adverse Incidents to Medical Devices to the MHRA – enhancements to the MORE portal
Adverse incidents involving medical devices which occur in the UK are reported to the MHRA via the MORE portal. The MHRA is in the process of implementing several changes to make the MORE portal automatized and easier to use. These updates are expected from June onwards. The MHRA have provided the following information: In our last update, we said that…
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 15 May)
Please note this is an extract of the original bulletin. Six new community diagnostic centres to deliver more than 500,000 lifesaving checks a year Page summary: New CDCs to open in regions across the UK, adding to the 106 centres already up and running and helping to cut NHS waiting lists Change made: First published. Health secretary attends Japan summit…
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May 26, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 15 May)
Please note this is an extract of the original bulletin. Additional funding for research on diseases spread by mosquitoes and ticks Page summary: An extra £2.35 million has been announced to improve the UK’s research capacity and capability around vector-borne disease. Change made: First published. Other animal by-products: model health certificates Page summary: Competent authorities of exporting countries should use…
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DSIT weekly update (WC 15 May)
Please note this is an extract of the original bulletin. UK and Japan strengthen science and tech ties in Tokyo Page summary: UK and Japan today signed a renewed science and technology deal, building on decades of close cooperation. Change made: First published. DSIT cyber security newsletter Page summary: A monthly newsletter detailing the latest DSIT announcements, events and projects…
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May 26, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 15 May)
Please note this is an extract of the original bulletin. Explanatory memorandum on EU regulation 2016/429 (2023)636 Page summary: The government’s summary of technical amendments to existing EU legislation to prevent and control the spread of certain listed diseases. Change made: First published. Businesses approved to export to the EU Page summary: Use the lists to check if your business…
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May 26, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DBT weekly update (WC 15 May)
Please note this is an extract of the original bulletin. UK to launch talks with Switzerland on new trade deal Page summary: UK Business and Trade Secretary, Kemi Badenoch, launches negotiations for a modern, updated free trade agreement with Switzerland. Change made: First published. UK-Switzerland enhanced free trade agreement negotiations Page summary: Documents relating to the UK and Switzerland’s negotiations for…
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May 19, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
BIVDA’s new Regulatory email
BIVDA has recently established a new email address dedicated to handling all regulatory enquiries. If you have any questions, concerns, or require assistance regarding regulatory matters or any events, we kindly ask you to contact our Regulatory Affairs email (Regulatory@bivda.org.uk). This will then be managed by either Ashleigh or Tehelj. If you are awaiting a response to any questions sent…
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May 19, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive, Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive
US EPA update (17 May)
Please note this is an extract of the original bulletin. Proposal removes low volume and exposure exemptions for new PFAS and other persistent chemicals, ensuring robust safety review WASHINGTON (May 16, 2023) — Today, the U.S. Environmental Protection Agency (EPA) proposed amendments to the regulations that govern the Agency’s review of new chemicals under the Toxic Substances Control Act (TSCA)…
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May 19, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 15 May)
Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Reference guides updated and new video tutorials added. MHRA fees Page summary: Fees payable…
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May 19, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 08 May)
Please note this is an extract of the original bulletin. Industrial Energy Transformation Fund Page summary: The Industrial Energy Transformation Fund (IETF) supports the development and deployment of technologies that enable businesses with high energy use to transition to a low carbon future. Change made: We will hold a consultation later this year to finalise the design of IETF Phase…
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May 19, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 08 May)
Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: Use the lists to check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to…
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May 19, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 15 May)
The Office for Life Sciences have published their latest updates. OLS Bulletin - 15 May OLS Borders Bulletin - 12 May These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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May 19, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 08 May)
Please note this is an extract of the original bulletin. Balai Directive: approved premises Page summary: Institutes, centres and premises in Great Britain approved to move animals, semen and embryos covered by the Balai Directive. Change made: Updated the Balai directive approved premises. Removed Tropical World, Leeds, from the list. Export lab mice to Hong Kong: certificate 6495 updated Page…
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May 19, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 08 May)
Please note this is an extract of the original bulletin. Personal Protective Equipment (Enforcement) Regulations 2018 Page summary: Guidance for businesses on Regulation 2016/425 and the Personal Protective Equipment (Enforcement) Regulations 2018. Change made: List of UK approved bodies updated in GB guide. Approved manufacturers: conformity assessment Page summary: Apply to become or identify an approved manufacturer authorised to…
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May 12, 2023 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Coronavirus Test Device Approvals Transition
The UK Coronavirus Test Device Approvals function is currently managed by UKHSA. The MHRA will take over this function from 24 May 2023. A guidance confirming the changes to process management will be published by the MHRA on 24 May. The MHRA have provided the following information: The UK Coronavirus Test Device Approvals regulatory regime is one of the most…
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May 12, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
REUL bill and programme update
The Retained EU Law (REUL) Bill was introduced with the intention of revoking the EU legislation from the UK by the end of 2023. Over the past year Whitehall departments have been working hard to identify REUL to preserve, reform or revoke. However, it has become clear that the default of retained EU law sunsetting at the end of this…
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May 12, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 01 May)
Please note this is an extract of the original bulletin. The Border Target Operating Model: Draft for Feedback Page summary: This page contains the draft Border Target Operating Model, setting out a new approach to importing into Great Britain that will be progressively introduced from the end of October 2023. Change made: The date of when the survey will…
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May 12, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 08 May)
Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Changes to DORS instructions for Scenarios 1 to 4 in the Guidance on registration…
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May 12, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 24 Apr)
Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: Use the lists to check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved to…
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May 12, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 01 May)
Please note this is an extract of the original bulletin. Designated standards: new or amended notices of publication Page summary: Proposed updates to the lists of standards for businesses. Change made: Proposals to amend added for equipment for explosive atmospheres and low voltage equipment. Time updated: 1:08pm, 2 May 2023 Simple Pressure Vessels (Safety) Regulations 2016 Page summary: Guidance…
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May 12, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 08 May)
The Office for Life Sciences have published their latest updates. OLS bulletin - 9 May OLS borders bulletin - 5 May These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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May 12, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
EU Notified bodies urging to submit Class D legacy devices’ application sooner
As the transitional deadlines for IVD devices are fast approaching, the Notified Bodies have communicated with MedTech Europe to encourage manufacturers to submit their applications for compliance with the IVD Regulation as early as possible. Manufacturers are urged to submit applications for Class D legacy devices before end-2023, in order to meet the deadline of 26 May 2025.
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May 12, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 01 May)
Please note this is an extract of the original bulletin. EM on EU decision to amend EU Regulation 2017/745 (COM(2022)721) Page summary: The Governments summary of a proposal of the European Parliament and the Council on fees and charges payable to the European Medicines Agency. Change made: First published. Time updated: 9:48am, 3 May 2023
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May 12, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 01 May)
Please note this is an extract of the original bulletin. Animal by-product operating plants: approved premises Page summary: Details of approved and registered animal by-product (ABP) operating plants in Great Britain and the Channel Islands. Change made: Updated the approved animal by-product plants in Great Britain list. Time updated: 2:06pm, 2 May 2023 Animal by-products for purposes outside the feed…
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May 12, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 01 May)
Please note this is an extract of the original bulletin. ESF Action Notes: 2014 to 2020 programme Page summary: Action notes to inform European Social Fund (ESF) grant recipients of an action they must complete. Change made: ESF Action Note Action required: Annual Review of 1720 Staff Hourly Rates that affect costs in the Q4 2023 claim has been…
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May 5, 2023 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA survey on PMS costs – deadline 17 May
To better understand the implications of proposed Post Market Surveillance (PMS) to manufacturers of medical devices, the MHRA would like to be provided with data on firms' expected cost of compliance with PMS regulations so far. This survey covers total costs of setting up a PMS system across an organisation, and the cost of maintaining a PMS. This firm level…
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May 5, 2023 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
UKCA statutory instrument published on implementation timelines
The UK Government have published an amendment to the UK Medical Device Regulations 2002. Notably, this is the first statutory instrument shaping the new UKCA requirements in Great Britain. BIVDA have provided our initial understanding of this text below. Please consult your own legal teams before acting on any of this advice, as it is our own interpretation. We…
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May 5, 2023 in European Chemicals Agency Updates Environmental Newsletter, European Chemicals Agency Updates Environmental Newsletter Archive, Industry newsletters Environmental Newsletter, Industry Newsletters Environmental Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
RoHS use information requested – deadline 26 May
Recently, BIVDA joined the Joint Trade Association, a collective of Trade Associations in the electronic space. This is in response to ongoing pressure with UK RoHS and the new fee associated with submitting applications of exemption under UK RoHS. We hope that by working with JTA, we will be able to support the BIVDA membership in submitting, or collating, UK…
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May 5, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive
BSI has adopted standard for electrical safety
BSI have adopted IEC 61010-2-101:2018 as a British standard. BS EN IEC 61010-2-101:2022/A11:2022 Safety requirements for electrical equipment for measurement, control, and laboratory use - Particular requirements for in vitro diagnostic (IVD) medical equipment considers electrical safety requirements for IVD equipment, and should be considered for manufacturers with products in this space.
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May 5, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 24 Apr)
Please note this is an extract of the original bulletin. Model health certificates for exports of live animals and animal products to Great Britain Page summary: Model health certificates (templates) for competent authorities and exporters in EU and non-EU countries that show import requirements for Great Britain, the Channel Islands and the Isle of Man. Change made: Clarified in the…
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May 5, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 24 Apr)
Please note this is an extract of the original bulletin. Reporting to the National Supply Disruption Response (NSDR) Page summary: Information on how to request assistance from NSDR. Change made: Updated language used from ‘how to report’ to ‘how to request assistance’ to describe the service more accurately. Lateral flow device (LFD) performance data Page summary: LFDs have proved vital…
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May 5, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 24 Apr)
Please note this is an extract of the original bulletin. Model health certificates for exports of live animals and animal products to Great Britain Page summary: Model health certificates (templates) for competent authorities and exporters in EU and non-EU countries that show import requirements for Great Britain, the Channel Islands and the Isle of Man. Change made: Clarified in the…
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May 5, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 24 Apr)
Please note this is an extract of the original bulletin. Medical devices – extended acceptance of CE marked medical devices on the Great Britain market Page summary: CE marked medical devices to be accepted in Great Britain for a longer period. Change made: First published.
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April 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 17 Apr)
Please note this is an extract of the original bulletin. Green Book supplementary guidance: valuation of energy use and greenhouse gas emissions for appraisal Page summary: Supplementary guidance to Treasury’s Green Book providing government analysts with rules for valuing energy usage and greenhouse gas emissions. Change made: Updated Data tables 1-19 to fix formatting errors. UK Innovation Survey Page…
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April 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 17 Apr)
Please note this is an extract of the original bulletin. UK border control posts: animal and animal product imports Page summary: Find an approved UK Border Control Post (BCP) to check the animals, animal products or high-risk food and feed of non-animal origin in your consignment. Change made: Updated entry for Heathrow Animal Reception Centre. Find a professional to…
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April 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 17 April)
The Office for Life Sciences have published their latest updates. OLS bulletin - 21 April OLS borders bulletin - 21 April These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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April 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 17 Apr)
Please note this is an extract of the original bulletin. Licensed waste facilities that accept waste F gas and ODS Page summary: A list of waste facilities that accept waste fluorinated greenhouse gas (F gas) and ozone-depleting substances (ODS). Change made: First published. Recovering, reclaiming and recycling F gas Page summary: How to recover fluorinated gas (F gas) from…
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April 28, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 17 Apr)
Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…
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April 28, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC weekly update (WC 17 Apr)
Please note this is an extract of the original bulletin. Safety and security requirements on imports and exports Page summary: Find out about safety and security requirements that apply to goods entering and exiting the UK. Change made: Appendix 1: entry summary declaration data elements for the S&S GB service has been updated to include a link to location…
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April 21, 2023 in BIVDA Updates Environmental Newsletter, BIVDA Updates Environmental Newsletter Archive, BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Environmental Newsletter, MedTech Europe Updates Environmental Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
Request for information on labelling
There is work ongoing within MedTech Europe on labelling of medical devices. To support in this work, MedTech Europe have requested the following information from industry by 28 April. Data on financial impact of additional labelling requirements arising from any jurisdiction. Costs of label development/production per major jurisdiction are welcome (e.g. to prepare a specific label for certain region/country; percentage of…
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April 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA extends MORE portal deadline to 31 August
MHRA have extended the deadline for their new MORE portal to 31 August. It was initially intended to be mandatory for vigilance reporting to MHRA from April. MHRA have provided the following information: The MHRA has been listening to feedback and engaging with device manufacturers and stakeholders since the new MORE portal was launched in November 2022. We understand that…
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April 21, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 10 Apr)
Please note this is an extract of the original bulletin. Businesses approved to export to the EU Page summary: Use the lists to check if your business in Great Britain or one of the Crown Dependencies is approved to export to the EU and find out what your TRACES number is. Change made: Updated the lists of businesses approved…
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April 21, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 10 Apr)
Please note this is an extract of the original bulletin. Balai Directive: approved premises Page summary: Institutes, centres and premises in Great Britain approved to move animals, semen and embryos covered by the Balai Directive. Change made: Updated approval date for Amazon World Zoo Park, New Forest Wildlife Park and Woburn Safari Park.Added Messingham Zoo Ltd to the list.…
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April 21, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 10 Apr)
Please note this is an extract of the original bulletin. Hewitt review: call for evidence Page summary: We want your views on how the oversight and governance of integrated care systems can best enable them to succeed. Change made: Added link to the Hewitt Review, which forms the outcome of this call for evidence.
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April 21, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 10 Apr)
Please note this is an extract of the original bulletin. Designated standards: machinery Page summary: Notices of publication and a consolidated list for designated standards for machinery. Change made: Notice of publication amended and consolidated list updated.
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April 21, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 10 Apr)
Please note this is an extract of the original bulletin. Green finance strategy Page summary: A strategy to harness the UK’s world-leading financial services sector to support our climate and environmental objectives. Change made: We have uploaded a web accessible version of the 2023 green finance strategy.
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April 14, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 3 Apr)
Please note this is an extract of the original bulletin. Develop a management system: environmental permits Page summary: How to develop a management system and keep it up to date so that you can carry out activities under an environmental permit. Change made: Updated the ‘A changing climate’ section. Explained when permit holders will need to meet the updated requirements…
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April 14, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 3 April)
The Office for Life Sciences have published their latest updates. OLS bulletin - 6 April OLS borders bulletin - 6 April These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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April 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 3 Apr)
Please note this is an extract of the original bulletin. UK’s next generation of medical researchers given funding boost Page summary: Investment is aimed at sparking a new wave of revolutionary medical research across the industry. Change made: First published. Occult hepatitis B infection in UK blood donors Page summary: Recommendations from the SaBTO occult hepatitis B infection (OBI) working…
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April 14, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 3 Apr)
Please note this is an extract of the original bulletin. MHRA fees Page summary: Fees payable to the MHRA for 2023 to 2024 Change made: Updated MHRA fees for 2023 – 2024 New statutory fees for MHRA services introduced from 1 April 2023 Page summary: Changes have been designed to ensure the agency is resourced to provide patients, the public…
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April 14, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 3 Apr)
Please note this is an extract of the original bulletin. Bovine germinal products: model health certificates Page summary: Competent authorities of exporting countries should use the relevant model health certificate as a template to create a version exporters can apply for to export bovine embryos to Great Britain, the Channel Islands or Isle of Man. Change made: Corrected the names…
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April 6, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 27 Mar)
Please note this is an extract of the original bulletin. Draft evaluations of 3 chemical substances proposed as Persistent Organic Pollutants (POPs): call for comments Page summary: Requesting comments on a draft risk profile and risk management evaluations for 3 chemical substances proposed as POPs to the UN’s POP review committee. Change made: First published. Imports, exports and…
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April 6, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC Supply Strategy and Continuity Team newsletter (March)
DHSC have issued the following newsletter for stakeholders: Life Sciences Innovative Manufacturing Fund announcement On Tuesday 28th March the Department for Science, Innovation and Technology announced the first phase of successful companies to receive £277 million of join government and private sector investment through the Life Sciences Innovative Manufacturing Fund and aimed at supporting UK long term health resilience.…
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April 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 27 Mar)
Please note this is an extract of the original bulletin. Export medical devices Page summary: Order a certificate of free sale to export medical devices outside the UK. Change made: Updated ‘Certificates of Free Sale for Medical Devices’ PDF. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines…
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April 6, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 27 Mar)
Please note this is an extract of the original bulletin. Life sciences companies supercharged with £277 million in government and private investment Page summary: Four life sciences companies from across the UK will benefit from the first tranche of Life Sciences Innovative Manufacturing Fund (LSIMF) grants. Change made: First published.
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April 6, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 27 Mar)
Please note this is an extract of the original bulletin. Treated raw materials for the production of gelatine and collagen intended for human consumption to the European Union and Northern Ireland: certificate 8398 updated Page summary: Apply online for an export health certificate (EHC) to export treated raw materials for the production of gelatine and collagen from Great Britain…
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April 6, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 27 Mar)
Please note this is an extract of the original bulletin. A pro-innovation approach to AI regulation Page summary: This white paper details our plans for implementing a pro-innovation approach to AI regulation. We’re seeking views through a supporting consultation. Change made: First published. Government responses to the Committee on Climate Change (CCC) annual progress reports Page summary: Government…
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April 6, 2023 in BIVDA updates Regulatory Affairs Newsletter, Membership News, Membership News Archive, Upcoming Events Regulatory Affairs Newsletter
TOPRA training discount for BIVDA members
TOPRA, The Organisation for Professionals in Regulatory Affairs, host a variety of training in the regulatory space that may be beneficial to BIVDA members. To encourage continued development of regulatory knowledge, we are partnering with TOPRA to offer a discount for BIVDA member organisations. A number of courses are planned this year, with a number involving BIVDA engagement: Regulation of…
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April 3, 2023 in BIVDA updates Regulatory Affairs Newsletter, BIVDA Updates Regulatory Affairs Newsletter Archive
CPD certificate available for BIVDA Spring Regulatory Seminar
If you attended the BIVDA Spring Regulatory Seminar on 8 March, you are eligible for a CPD certificate. If you would like to receive a certificate for your CPD log, please contact Natalie to request one (natalie@bivda.org.uk).
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April 3, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 27 Mar)
The Office for Life Sciences have published their latest updates. OLS borders bulletin - 24 Mar OLS bulletin - 23 Mar These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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April 3, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive
UL free webinar on UKCA for IVD medical devices
UL have made available a 30 minute webinar on the upcoming UK Medical Device Regulation changes. This is a free webinar available from the UL website. It covers current timelines, expected requirements based on the MHRA consultation response, and transitional arrangements.
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April 3, 2023 in Consultations, Consultations Archive, European Chemicals Agency Updates Environmental Newsletter Archive, European Commission Updates Environmental Newsletter, European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
European Commission consultation on Directive to promote the repair of goods
The European Commission have launched a public consultation on their proposal for a Directive on common rules promoting the repair of goods. This consultation is open until 22 May. This initiative promotes a more sustainable use of goods throughout their useful life. It will encourage consumers to make more sustainable choices by providing incentives and tools to use goods for…
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March 31, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC communication on plastic packaging tax
HMRC have provided the following update for stakeholders: As announced at Spring Budget, the PPT rate will be increased from £200 per tonne to £210.82 per tonne in line with the Consumer Price Index (CPI) from 1 April 2023. This change will maintain the real term value of the price incentive to use recycled plastic and supports the government’s environmental…
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March 31, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. Regulations: restriction of hazardous substances (RoHS) Page summary: Guidance for manufacturers, importers and distributors. Change made: Notifications guidance and form updated.
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March 31, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
UKHSA weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. UK SMI S 12: sepsis and other systemic and disseminated infections Page summary: This consultation asks for feedback on UK Standards for Microbiology Investigations S 12: sepsis, and other systemic and disseminated infections. Change made: Added Review of users’ comments for S 12 Sepsis and systemic or disseminated infections.
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March 31, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Foreign, Commonwealth and Development Office weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. Agenda of the tenth meeting of the Withdrawal Agreement Joint Committee: 24 March 2023 Page summary: This document provides the agenda for the tenth meeting of the Withdrawal Agreement Joint Committee on 24 March 2023 in London. Change made: First published. Agenda of the second meeting of the…
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March 31, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. Register or renew waste exemptions Page summary: When your waste operation does not need a permit but you may need to register. Change made: Added that you cannot carry out or register an exempt waste operation at an installation. Regulations: restriction of hazardous substances (RoHS) Page summary: Guidance…
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March 31, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. Consultation on proposals for legislative changes for clinical trials Page summary: We are consulting on a set of proposals to improve and strengthen the UK clinical trials legislation to help us make the UK the best place to research and develop safe and innovative medicines Change made: Government response…
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March 31, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. Submitting an application for review by the ACBS Page summary: How to apply to have nutritional or dermatological products reviewed by the Advisory Committee on Borderline Substances (ACBS). Change made: Added ‘11 March 2024 – closing date for submissions is 15 January 2024’ under the heading ‘ACBS meetings and…
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March 31, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Added Dilliway and Bosley Equine Veterinary Practice to the list of…
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March 31, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA has confirmed EU amendment to MDR will apply in Northern Ireland
MHRA have confirmed that the timeline extensions for the EU MDR will apply in Northern Ireland, and certificates that have been extended will be recognised as valid for placing CE marked devices on the Great Britain market. This comes after the EU passed an amendment to the EU MDR and EU IVDR to amend the transition timelines for medical devices,…
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March 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 13 Mar)
Please note this is an extract of the original bulletin. Recycled materials in consumer products Page summary: An independent research report. Change made: First published.
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March 24, 2023 in BIVDA Updates Environmental Newsletter Archive, BIVDA updates Regulatory Affairs Newsletter
BIVDA Spring Regulatory Affairs Seminar took place on 8 March
The Seminar covered the following topics: MHRA Software Roadmap with Johan Ordish (MHRA) MHRA IVD Roadmap, UKCA, and the Life Science Review with Ashleigh Batchen (BIVDA), Tom Beale (Agilent Technologies) and Camilla Fleetcroft MDCG Roadmap with Andrew Rutter (QuidelOrtho) Class D IVDs with Erica Conway (MCRA) BSI Standards with Rob Turpin (BSI) US Regulatory Process Stuart Angell (IVDeology) The event…
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March 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 13 Mar)
Please note this is an extract of the original bulletin. APHA laboratory test submissions and price lists Page summary: Guidance on the Animal and Plant Health Agency laboratory testing services and prices for animal disease diagnosis. Change made: Export and ABC price list updated. Find a professional to certify export health certificates Page summary: A list of organisations…
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March 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. UK Critical Minerals Strategy Page summary: This is the UK’s first-ever critical minerals strategy that aims to improve the security of supply of critical minerals. Change made: Critical Minerals Refresh: Delivering Resilience in a Changing Global Environment published. Regulations: restriction of hazardous substances (RoHS) Page summary: Guidance for…
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March 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Department for Business and Trade consultation on the minimum energy performance standard for lighting products
DHSC have provided the following update for stakeholders: The Department for Business and Trade has released a live public consultation to seek views on a proposal to increase the minimum energy performance standard for lighting products placed on the Great Britain market from 2023 and again from 2027. The consultation may be of interest to those: in the lighting sector…
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Cabinet Office weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. New rules for importing and exporting goods Page summary: Importing: an overview Change made: Updated to reflect the change from Department for International Trade to Department for Business and Trade
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC weekly update (WC 20 Mar)
Please note this is an extract of the original bulletin. Get a goods movement reference: check service availability and issues Page summary: Check the availability and any issues affecting the get a goods movement reference service. Change made: Updated to confirm there is planned maintenance work on the Customs Declaration Service from 9:30pm on Saturday 25 March 2023 to…
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 13 Mar)
Please note this is an extract of the original bulletin. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…
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March 24, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 13 Mar)
Please note this is an extract of the original bulletin. Philip Duffy appointed new Environment Agency Chief Executive Page summary: Philip Duffy has been appointed as the new Chief Executive of the Environment Agency (EA) and will start in the role on 1 July. Change made: First published. Businesses approved to export to the EU Page summary: Use the…
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Consultation response on legislative proposals for clinical trials published by MHRA
MHRA has published the consultation response on their proposals for legislative changes for clinical trials. "We will introduce new legislation and guidance as part of a swathe of new measures that represent the biggest overhaul in UK clinical trials regulation in over 20 years. These bold new measures will make the UK one of the best countries in the world…
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March 24, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Membership News
EU IVDR amendment published in the OJEU
The amendment to the EU IVDR has been published in the Official Journal of the European Union. This removes the sell-off provision for IVD products, meaning that IVDs legally placed on the market under their IVDD certification can continue to be supplied to users indefinitely. This does not mean that new product can be placed on the market after expiry…
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March 24, 2023 in Upcoming Events Environmental Newsletter, Upcoming Events Environmental Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive
Assent webinar: 2023 UFLPA Update: Enforcement Is on the Rise – Can You Risk Product Seizures?
Assent have hosted a free webinar on UFLPA Update: Enforcement Is on the Rise — Can You Risk Product Seizures? This is available on-demand on the Assent website. The webinar includes discussions on: The CBP’s approach to forced labor investigations Methods to conduct due diligence that hold up to scrutiny How to uncover supplier connections to sanctioned parties
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA publishes new software guidance for intended purpose
MHRA has published a new guidance page for developing an intended purpose in the context of Software as a Medical Device (SaMD). We encourage all members who make software products as a medical device should review this guidance for the UK market.
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March 24, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Draft statutory instrument for the Windsor Framework published
The draft statutory instrument on the Windsor Framework has been published. This will now go through a vote in the House of Commons, but is likely to be implemented into UK law. Secondary legislation will then be developed in order to action the contents of the Framework. BIVDA have requested confirmation from MHRA and DHSC on how this Framework will…
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March 24, 2023 in Funding/Grant Opportunities Environmental Newsletter, Funding/Grant Opportunities Environmental Newsletter Archive, Funding/Grant Opportunities Regulatory Affairs Newsletter, Funding/Grant Opportunities Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive
Innovate UK (UKRI) launches new funding competition
These programmes will focus on the future economy as described in our plan for action. The Future Economy investor partnership programme brings together: Innovate UK’s expertise in identifying innovation and using grant funding to change the risk profile of businesses investor partners’ aligned funding and expertise in identifying opportunities and teams that can best use extra investment finance More information…
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March 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA request to engage earlier for safety issues
MHRA have requested that we remind members to engage with MHRA as soon as possible on matters relating to safety. Where you think you may need to utilise the exceptional use authorisation route, or are unsure on vigilance obligations, we encourage you to contact MHRA directly for support. The EUA route can be used for any medical device or IVD…
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March 17, 2023 in European Commission Updates Environmental Newsletter, European Commission Updates Environmental Newsletter Archive, European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Environmental Newsletter, MedTech Europe Updates Environmental Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
Public consultation on proposed Ecodesign for Sustainable Products Regulation (ESPR)
There is an ongoing public consultation on priorities under the Ecodesign for Sustainable Products Regulations (ESPR). This consultation is open until 12 May. It is possible that this could affect certain medical devices such as adult incontinence products or substances used in production of medical devices and IVDs. Members are encouraged to review this consultation and provide feedback directly by…
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March 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Regulatory Affairs Newsletter
DEFRA weekly update (WC 6 Mar)
Please note this is an extract of the original bulletin. The use of lead and cadmium in ion selective electrodes Page summary: Seeking your views on an application to exempt the use of lead and cadmium in ion selective electrodes from the RoHS Regulations. Change made: We added the government’s response to the consultation. Businesses approved to export to the…
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March 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 6 Mar)
Please note this is an extract of the original bulletin. Horizon Europe guarantee: updates for the UK research and development sector Page summary: The latest information on the guarantee to provide funding for successful UK applicants to Horizon Europe. Change made: Added link to Horizon Europe Guarantee press release announcing the latest extension which will support eligible, successful applicants, covering…
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March 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 6 Mar)
Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Imports of poultry, ratite and wild game bird meat into Great Britain from Argentina that were slaughtered on or after 28 February…
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March 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 6 Mar)
Please note this is an extract of the original bulletin. Advisory Group Reform Proposals Page summary: Update to the Life Sciences Council Joint Statement on Medical Devices Regulatory Reform. Change made: First published. MHRA fees Page summary: Fees payable to the MHRA for 2022 to 2023 Change made: Added link to application form to ‘apply for Small and Medium Company…
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March 17, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 6 Mar)
Please note this is an extract of the original bulletin. Government to consider radical new approach to prevent life-threatening cardiovascular disease Page summary: Professor John Deanfield, CBE announced as the first ever Government Champion for Personalised Prevention Change made: First published. Minister meets leading researchers in women’s health and calls for more women working in STEM Page summary: Today (Monday…
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March 17, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications (WC 13 Mar)
The Office for Life Sciences have published their latest updates. OLS borders bulletin - 10 Mar OLS bulletin - 15 Mar These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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March 17, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive
MDCG guidance schedule
The MDCG have published their latest ongoing guidance update. The following IVDR-related documents are included in this list: Notified bodies Q&A on requirements notified bodies – update of MDCG 2019-6 (Permanent work item, no estimated date) Standards Updates of guidance document MDCG 2021-5 on standardisation for medical devices (Estimated Q2 2023) Post-market surveillance and vigilance Guidance on Post-Market Surveillance requirements (Estimated Q2…
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March 9, 2023 in BIVDA Updates Environmental Newsletter, BIVDA updates Regulatory Affairs Newsletter, European Commission Updates Environmental Newsletter, FDA updates Regulatory Affairs Newsletter, Funding/Grant Opportunities Regulatory Affairs Newsletter, MedTech Europe Updates Environmental Newsletter, Other Updates Environmental Newsletter, Other Updates Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications WC 6 Mar
The Office for Life Sciences have published their latest updates. OLS borders bulletin - 3 Mar OLS bulletin - 6 Mar These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC webinar on the Windsor Framework
DHSC have provided the following update for stakeholders: DHSC would like to invite you to a webinar at 2pm on Thursday 16 March, on the recent announcement from the Government on the significant changes to medicines in the Windsor Framework. We will be joined by colleagues from MHRA, and will be discussing: The replacement of the EMA by the MHRA…
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March 9, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
EU MDR/EU IVDR amendment approved by EU Council
On 7 March, the European Council unanimously approved the amendment to the EU MDR and EU IVDR. This amends the transitional provisions for the MDR and removes the sell-off provision for IVDs. This is expected to be published in the Official Journal of the European Union this month, which will be when it comes into force. MedTech Europe's press release…
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 27 Feb)
Please note this is an extract of the original bulletin. Businesses urged to get ready for reforms to cut packaging waste Page summary: Reporting requirements for the Extended Producer Responsibility scheme for packaging come into force today. Change made: First published. Request for information about risk management evaluations of substances proposed as Persistent Organic Pollutants (POPs) Page summary: Collecting…
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 27 Feb)
Please note this is an extract of the original bulletin. Imports, exports and EU trade of animals and animal products: topical issues Page summary: Current issues relating to imports and exports of animals and animal products. Change made: Updated the ‘Avian influenza (bird flu) outside the UK’ section. The surveillance period for imports of live animals and fresh poultry meat…
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 27 Feb)
Please note this is an extract of the original bulletin. Designated standards: low voltage Page summary: Notices of publication and a consolidated list for designated standards for low voltage electrical equipment. Change made: Notice of publication amended and consolidated list updated.
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (WC 27 Feb)
Please note this is an extract of the original bulletin. MHRA Graduate Scheme Page summary: Information about the MHRA’s Graduate Scheme and how to apply. Change made: First published. Working for MHRA Page summary: Information on how to apply for jobs, workplace benefits and skills development at the Agency. Change made: Added link to MHRA graduate Scheme. Medical…
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 27 Feb)
Please note this is an extract of the original bulletin. England Rare Diseases Action Plan to tackle health inequalities Page summary: The 2023 England Rare Diseases Action Plan goes further than ever before to support people living with rare diseases. Change made: First published. England Rare Diseases Action Plan 2023 Page summary: The second action plan setting out how…
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
OPSS weekly update (WC 20 Feb)
Please note this is an extract of the original bulletin. Restriction of hazardous substances (RoHS) exemptions for electrical and electronic equipment: how to apply Page summary: How to apply for an exemption to use a restricted substance to manufacture electrical and electronic equipment. Change made: From 6 April 2023, you’ll need to pay an administration fee if you apply for…
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
MHRA weekly update (20 Feb)
Please note this is an extract of the original bulletin. Impact of extension of Medical Device Regulations transitional period and the validity of certificates in the EU Page summary: The EU Commission has voted to adopt an extension of the transition period for the EU Medical Device Regulations and to extend the validity of certain device certificates Change made: First…
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC weekly update (WC 20 Feb)
Please note this is an extract of the original bulletin. Plans to bolster patient safety and boost support for frontline staff by streamlining the system for healthcare regulators Page summary: The government will streamline the system to modernise regulatory legislation to boost patient safety and support staff Change made: First published. Lord O’Shaughnessy to lead independent review into UK…
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DEFRA weekly update (WC 20 Feb)
Please note this is an extract of the original bulletin. Calculate the carbon dioxide equivalent quantity of an F gas Page summary: Find out how to express the mass of a fluorinated greenhouse gas (F gas) in terms of carbon dioxide equivalent so that you comply with regulations on F gases. Change made: Added ‘metric’ to metric tonnes for clarification.…
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
BEIS weekly update (WC 20 Feb)
Please note this is an extract of the original bulletin. Evaluation of the Provision of Services Regulations 2009 Page summary: Evaluation finding on the Provision of Services Regulations 2009 to understand their impact, assess the extent to which they remain fit for purpose, and identify areas for improvement. Change made: First published.
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
APHA weekly update (WC 20 Feb)
Please note this is an extract of the original bulletin. Find a professional to certify export health certificates Page summary: A list of organisations in England, Scotland and Wales that inspect and certify animals and animal products for export. The list does not include every certifier. Change made: Updated name and contact details for ATD Export Services Limited in the…
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
HMRC communication on plastic packaging tax
HMRC have provided the following update for stakeholders: Plastic Packaging Tax (PPT) was introduced on 1 April 2022. If you manufacture or import 10 or more tonnes of plastic packaging within a 12 month period you must register for PPT on GOV.UK even if your packaging contains 30% or more recycled plastic. You need to register for PPT if: you…
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive
DHSC MedTech Directorate holding webinar on the Medical Technology Strategy
DHSC have provided the following update for stakeholders: The DHSC Medical Technologies Directorate is hosting a webinar on Monday 6 March 2023 at 11:00 – 12:00 to promote the newly published Medical Technology Strategy which was shared with you on 3 February 2023 (https://www.gov.uk/government/publications/medical-technology-strategy). The Government’s inaugural Medical Technology Strategy sets out how we will ensure the health and social…
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March 9, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Membership News, Membership News Archive
Reminder: BSI looking for contributors for safety requirements for electrical equipment for measurement, control and laboratory use standard
A reminder that BSI have put a call out for those interested and knowledgeable in the field of electrical equipment for measurement, control and laboratory use, specifically for IVD equipment (BS EN 61010-2-101:2017, BS EN 61010-2-101:2017). This is to join their committee EPL/66, Safety of measuring, control and laboratory equipment’ in developing the above standard which is undergoing a revision.…
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March 9, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
Team-NB position paper published: guidance for submission of technical documentation
Team-NB have published the position paper Best Practice Guidance for the Submission of Technical Documentation under Annex II and III of In Vitro Diagnostic Medical Device Regulation (EU) 2017/746. This is listed as "Team-NB PositionPaper BPG-IVDR V1" on the Team-NB website. Please note that although this is a guidance document published by a collective group of Notified Bodies, it is…
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March 9, 2023 in UK Government Updates Environmental Newsletter, UK Government Updates Environmental Newsletter Archive, UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
Office for Life Sciences – publications WC 20 Feb
The Office for Life Sciences have published their latest updates. OLS bulletin - 21 Feb These include updates on news, including the Russia/Ukraine conflict, regulatory updates, transitional guidance and events
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March 9, 2023 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
MedTech Europe survey results: Transition to the IVD Regulation
MedTech Europe have published their Survey Report Transition to the IVD Regulation - MedTech Europe Survey Results for October 2022. This report can be found on the MedTech Europe website. The results demonstrate that there are still bottlenecks occurring throughout the IVDR implementation, and indicates where additional attention is needed.
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March 9, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive, MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
EMA pilot launched for expert panels on high risk medical devices
For class III implantable devices, class IIb active devices intended to administer or remove medicinal products from the body, and Class D in vitro diagnostic medical devices, the Regulations on Medical Devices (Regulation (EU) 2017/745) and on In Vitro Diagnostic Devices (Regulation (EU) 2017/746) require notified bodies to consult expert panels before issuing a CE certificate. EMA is now running a pilot that enables the expert panels to…
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March 9, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive
DHSC notice on the Windsor Framework
DHSC have provided the following update for stakeholders: You will have seen the announcement yesterday on the Windsor Framework, which concludes an agreement between the UK and the EU on the Northern Ireland Protocol. This framework includes simplifications to customs and Sanitary and Phytosanitary (SPS) processes that will significantly reduce requirements on traders. We are working through the details of…
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March 9, 2023 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive
Third edition of Clinical Evidence Requirements under the IVDR eBook published
MedTech Europe have published the third version of their Clinical Evidence Requirements under the EU In Vitro Diagnostics Regulation eBook. This can be found on the MedTech Europe website.
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November 18, 2022 in Membership News, Membership News Archive, Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Latest UKCA extensions do not apply to medical devices
This includes: The General Product Safety Regulations 2005 Supply of Machinery (Safety) Regulations 2008 Electromagnetic Compatibility Regulations 2016 Pressure Equipment Safety Regulations 2016 Electrical Equipment (Safety) Regulations 2016 Simple Pressure Vessels (Safety) Regulations 2016 Radio Equipment Regulations 2017 These timelines have been extended for 12 months to allow extra time for compliance. Importantly, these timeline changes do not impact medical…
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Regulations: ecodesign of energy-consuming products – Regulatory Affairs Newsletter #1
Guidance for manufacturers, their authorised representatives and importers. Change made: Declaration of Conformity template added. Other pages commonly used European Commission updates MedTech Europe updates HSE eBulletins UKRI updates Home Office updates Office for Life Sciences bulletin Cabinet Office weekly update (extract of original bulletin) Environmental Agency weekly update (extract of original bulletin) MDCG updates Could consider Upcoming regulatory or…
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
MHRA innovation case studies – Regulatory Affairs Newsletter #1
Case studies demonstrating how MHRA has helped a number of companies navigate the regulatory processes for innovative new medicines and medical devices. Change made: Added ‘Horizon Scanning Case Study: Point of Care manufacture’ to the collection.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Innovation Accelerator – Regulatory Affairs Newsletter #1
Provide innovators and developers of innovative products access to MHRA scientific expertise, regulatory guidance and an enhanced advice and signposting service. Change made: First published.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Horizon Scanning Case Study: Point of Care manufacture – Regulatory Affairs Newsletter #1
Horizon scanning at the MHRA leads to a proposed new framework to enable the supply and increase in the availability of innovative new medicinal products made at the point of care to patients. Change made: First published.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
MHRA weekly update – Regulatory Affairs Newsletter #1
Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or cancellation. Change made: Updated ‘Open List’
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Health and Care Act 2022: adult social care provider information provisions – Regulatory Affairs Newsletter #1
Guidance for adult social care providers to comply with information provisions under section 99 and section 100 of the Health and Care Act 2022. Change made: First published.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Coronavirus Act report: May 2022 – Regulatory Affairs Newsletter #1
The thirteenth two-monthly report on which powers in the Coronavirus Act 2020 are currently active. Change made: Added a correction slip to the report, detailing revisions to the document on pages 4 and 11.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Businesses approved to export to the EU – Regulatory Affairs Newsletter #1
Page summary: Use the lists to check your business in Great Britain (England, Scotland and Wales) or one of the Crown Dependencies (Jersey, Guernsey and Isle of Man) is approved to export to the EU, and find out what your TRACES number is. Change made: Updated the lists of businesses approved to export to the EU.
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
BIVDA updates – Regulatory Affairs Newsletter #1
Places are filling up for the BIVDA Joint Working Party and Regulatory Affairs Seminar! If you are looking to attend Working Party meetings or the Regulatory Affairs Seminar, we encourage you to register as soon as possible to prevent disappointment. The agenda for these are being finalised, but the seminar is aiming to cover: Summary of what is going on…
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September 28, 2022 in Regulatory Affairs Newsletter, Regulatory Affairs Newsletter Archive
Summary – Regulatory Affairs Newsletter #1
The BIVDA Joint Working Party and annual Regulatory Affairs Seminar is approaching on 12-13 October. Members are encouraged to book tickets as soon as possible to prevent disappointment – places are filling up fast!
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