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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 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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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 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 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 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 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 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 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 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 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 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 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 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 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 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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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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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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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 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 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 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 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 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 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 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 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 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 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 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 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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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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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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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 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 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 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 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 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 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 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 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 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 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 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 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 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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