Skip to main content

Regulatory

July 10, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 01 Jul)

Please note this is an extract of the original bulletin. 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: Updated ‘DEKRA Certification UK Ltd medical devices scope’. *Note: IVD devices are not in scope Medical devices given exceptional use authorisations during the COVID-19 pandemic…
Read More
July 10, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 01 Jul)

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: Guidance updated to reflect closing of new suspensions window that ran from 8 May 2024 to 3 July 2024. UK-Australia FTA Joint Committee Statement…
Read More
July 10, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

MDCG guidance on the classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746

On 08 July, the Medical Device Coordination Group (MDCG) published MDCG 2020-16 Rev. 3 guidance on "the classification rules for in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2017/746". This document provides updates from the previous revision released in February 2023. These include: Addition of ‘kit’ definition Revision of examples for Rule 3(a) and Rule 6 Revision of Rule…
Read More
July 10, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 01 Jul)

Small Entity Compliance Guide: Laboratory Developed Tests The U.S. Food and Drug Administration (FDA) have issued a Small Entity Compliance Guide (SECG) to assist small entities in complying with FDA regulations as they apply to in vitro diagnostic (IVD) products, including laboratory developed tests (LDTs). The LDT final rule published on May 6, 2024, amends the FDA’s regulations to make…
Read More
July 10, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

Regulation (EU) 2024/1860 published on Official Journal of the European Union

On 09 July, the Regulation (EU) 2024/1860 amending the EU MDR and EU IVDR has been published in the Official Journal of the European Union (OJEU). This amends the EU MDR and EU IVDR by: Further extending the transition period for certain IVDs as long as they meet certain conditions. These devices can benefit from the following transitional period: 31…
Read More
July 3, 2024 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 24 Jun)

Please note this is an extract of the original bulletin. Go-live for the swissdamed Actors module Since 26 May 2021, Swiss economic operators (manufacturers, importers and authorised representatives) have had to register with Swissmedic in order to obtain a unique registration number (Swiss Single Registration Number – CHRN). The Actors module of swissdamed will be available from 6 August 2024. After…
Read More
June 25, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Membership News, Membership News Archive

IMDRF publishes “In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)”

On 25 June, the IMDRF published their updated "In Vitro Diagnostic Device Regulatory Submission Table of Contents (IVD ToC)." This document sets out significant revisions based on regional policy changes since the last update was published in 2019. The table of contents is designed to support IVD regulatory submissions. IMDRF have confirmed that companion diagnostics are in scope but clinical…
Read More
June 25, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

UKHSA weekly update (WC 17 Jun)

Please note this is an extract of the original bulletin. Antimicrobial intravenous-to-oral switch: criteria for prompt switch Page summary: National antimicrobial intravenous-to-oral switch (IVOS) criteria for prompt switch​ have been developed for adult and paediatric patients, categorised into 5 sections. Change made: Added decision guide for paediatrics.
Read More
June 19, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 10 Jun)

Please note this is an extract of the original bulletin. Software and artificial intelligence (AI) as a medical device Page summary: Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). Change made: Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices…
Read More
June 19, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 10 Jun)

Please note this is an extract of the original bulletin. UK-New Zealand Joint Committee ministerial statement Page summary: Details of the Joint Committee held as part of the United Kingdom-New Zealand Free Trade Agreement on 8 May 2024. Change made: First published. Export control licensing management information for Israel Page summary: Export control licensing management information from 7 October 2023…
Read More
June 12, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 03 Jun)

Importing H5 Avian Influenza Samples On June 6, the Federal Select Agent Program announced a new H5 Avian Influenza Virus Exemption. The Administrator of the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) has utilized his exemption authority under 9 C.F.R. 121.5(f) in the select agent and toxin regulations to temporarily exempt H5 avian influenza viruses…
Read More
June 12, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 03 Jun)

Please note this is an extract of the original bulletin. National Academy focused on Mathematical Sciences: (closed to applications) Page summary: Open competition for up to £6 million of grant funding to support the establishment of a new incipient National Academy focused on Mathematical Sciences to represent the mathematical sciences community in the UK. Change made: Application window has closed.…
Read More
June 12, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 03 Jun)

Please note this is an extract of the original bulletin. Open general export licence chemicals Page summary: Licence allowing certain chemicals to be exported from the UK to permitted destinations. Change made: The current version of the OGEL has been revoked. Certain chemicals have been removed following regime changes and associated legislation that came into force on 2 April 2024.…
Read More
June 5, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

UKHSA weekly update (WC 27 May)

Please note this is an extract of the original bulletin. UKHSA Commercial and Partnerships Page summary: This guidance is designed to help UKHSA customers and partners to navigate engaging and working with us and to signpost upcoming events and opportunities. Change made: Removed reference to postponed event.
Read More
June 4, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

Public consultation: conflict-of-interest rules under the EU Health Technology Assessment Regulation

The European Commission have launched an online public consultation on the draft implementing act on the management of conflicts of interest in Health Technology Assessments. The draft implementing act provides rules for managing conflicts of interest of actors such as the representatives in the Member State Coordination Group and its subgroups, assessors, patients, and clinical and other experts who participate…
Read More
June 4, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 May)

Please note this is an extract of the original bulletin. Our governance Page summary: The main decision-making, executive and managerial bodies at the Medicines and Healthcare products Regulatory Agency (MHRA). Change made: Updated board members and executive committee lists
Read More
May 29, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 20 May)

Please note this is an extract of the original bulletin. Implementation of medical devices future regime Page summary: A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition. Change made: Updated to include intended policy on international recognition and consultation on common specifications for in vitro diagnostic medical…
Read More
May 29, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 20 May)

Please note this is an extract of the original bulletin. EM on EU regulations 2017/745 & 2017/746 (COM(2024)43) Page summary: The government’s summary of changes to the transitional arrangements for the supply of certain in vitro diagnostic medical devices within the European Union. Change made: First published.  
Read More
May 29, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 20 May)

Please note this is an extract of the original bulletin. Government's trailblazing Institute for AI Safety to open doors in San Francisco Page summary: Technology Secretary Michelle Donelan announces first AI Safety Institute overseas office in San Francisco. Change made: First published. New independent Institute to steer UK semiconductor innovation and support semiconductor strategy Page summary: UK Semiconductor Institute announced…
Read More
May 29, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 20 May)

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: Consultation outcome updated. Conformity assessment testing under mutual recognition or free trade agreements Page summary: When you can use a designated UK-based conformity…
Read More
May 29, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 20 May)

FDA Webinar: Enforcement Policies for Certain In Vitro Diagnostic Devices - Draft Guidances The U.S. Food and Drug Administration (FDA) is announcing a webinar to discuss draft guidances: Enforcement Policy for Certain In Vitro Diagnostic Devices for Immediate Public Health Response in the Absence of a Declaration under Section 564,when finalized, will describe the FDA’s enforcement policy for certain laboratory…
Read More
May 22, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes draft policy statement on International recognition of medical devices

The MHRA have published a statement of policy intent for recognition of approvals of medical devices from international regulators by the UK. This statement of policy intent is intended to inform partners of the MHRA’s direction of travel.  The legislation will come into being at the same time as the future core regulations – anticipated to be late in 2024…
Read More
May 22, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 13 May)

Please note this is an extract of the original bulletin. MHRA announces dedicated new team to support the international community in tackling antimicrobial resistance Page summary: Backed by a new award of £1.8 million, the Medicines and Healthcare products Regulatory Agency (MHRA) is to establish a dedicated team to provide regulatory scientific support for innovators creating novel antimicrobials and diagnostics…
Read More
May 22, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 13 May)

Please note this is an extract of the original bulletin. New Zealand: UK Science and Innovation Network summary Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in New Zealand including UK SIN priorities and successes Change made: First published. Call for views on the Code of Practice for Software Vendors Page summary: The…
Read More
May 22, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 13 May)

Please note this is an extract of the original bulletin. UK Sustainability Reporting Standards Page summary: Information on the UK government’s framework to create UK Sustainability Reporting Standards (UK SRS) by assessing and endorsing the global corporate reporting baseline of IFRS Sustainability Disclosure Standards. Change made: Updates made regarding UK Sustainability Reporting Standards following the publication of a Framework Document…
Read More
May 22, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

Cystic Fibrosis Trust Industry Symposium

The Cystic Fibrosis Trust are hosting an industry symposium "Accelerating CF Research: Strategies for rapidly progressing your science to clinical impact" on the 05 June 2024 in Glasgow. This event aims to showcase the support available for researchers to tap into and ways to accelerate their research projects. More information on this event and registration can be found here.
Read More
May 14, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 06 May)

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: Updated to feature a new 2024 tariff suspensions window. UK-Vietnam committee documents Page summary: Decisions, documents and meeting minutes from the UK-Vietnam committees. Change…
Read More
May 14, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 06 May)

Please note this is an extract of the original bulletin. AI Safety Institute releases new AI safety evaluations platform Page summary: The AI Safety Institute has open released a new testing platform to strengthen AI safety evaluations. Change made: First published. Australia: UK Science and Innovation Network summary Page summary: A summary from UK Science and Innovation Network (SIN) on…
Read More
May 14, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 06 May)

Please note this is an extract of the original bulletin. Update on pioneering initiative on regulation and evaluation of digital mental health technologies Page summary: An MHRA and NICE partnership, funded by Wellcome, is addressing key challenges for regulating and evaluating digital mental health technologies (DMHTs) with input from patients, the public and mental health professionals. Change made: First published.…
Read More
May 14, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 06 May)

Please note this is an extract of the original bulletin. Antimicrobial resistance (AMR) Page summary: Information and resources on the UK’s plans to see antimicrobial resistance contained and controlled by 2040. Change made: Added ‘UK 5-year action plan for antimicrobial resistance 2024 to 2029’. New 5-year plan to combat antimicrobial resistance Page summary: The government has announced its new national…
Read More
May 8, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 29 Apr)

Please note this is an extract of the original bulletin. Impact of AI on the regulation of medical products Page summary: Implementing the Artificial Intelligence (AI) White Paper principles. Change made: First published. MHRA’s AI regulatory strategy ensures patient safety and industry innovation into 2030 Page summary: The MHRA has today set out its strategic approach to artificial intelligence (AI)…
Read More
May 8, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 29 Apr)

Please note this is an extract of the original bulletin. New laws to protect consumers from cyber criminals come into force in the UK Page summary: From today, regulations enforcing consumer protections against hacking and cyber-attacks will take effect, mandating that internet-connected smart devices meet minimum-security standards by law. Change made: First published. Switzerland: UK Science and Innovation Network summary…
Read More
May 8, 2024 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 achieving net zero goals

BSI are hosting a free webinar on how a small business can achieve net zero goals on 11 June. The webinar will include include an introduction to BSI Flex 3030 and what it aims to do, user community discussion on BSI Flex 3030, how best it can be applied, and its impact, a Q&A session and audience feedback and introduction…
Read More
May 8, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 29 Apr)

Please note this is an extract of the original bulletin. Placing manufactured products on the market Page summary: Find out which standards and regulations apply to your product and how to make sure you follow the right procedures. Change made: Conformity assessment section updated with link to ‘Conformity assessment testing under mutual recognition or free trade agreements’ page. Notice to…
Read More
May 1, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. Spain: UK Science and Innovation Network Country Snapshot Page summary: A summary from UK Science and Innovation Network (SIN) on science and innovation in Spain including UK SIN priorities and successes. Change made: Summary fully reviewed and updated, Regulations: consumer connectable product security Page summary: Guidance for manufacturers, importers and…
Read More
May 1, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 22 Apr)

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: The Health Claims (Revocation) Regulations 2024 SI added to the page under the…
Read More
May 1, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 22 Apr)

Please note this is an extract of the original bulletin. 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: Added: LNE-GMED UK Limited in-vitro medical devices scope. LNE-GMED UK Limited active implantable medical devices scope Notify MHRA about a clinical investigation for a medical…
Read More
May 1, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

IMDRF publishes a new guidance document

The IMDRF have published a new guidance document "Principles of Labeling for Medical Devices and IVD Medical Devices" (IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2)). This document provides a globally harmonized labeling principles for medical devices, including in vitro diagnostic (IVD) medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). This document…
Read More
May 1, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 29 Apr)

FDA Takes Action to Help Ensure the Safety and Effectiveness of Laboratory Developed Tests Page Summary: On 29 April, the U.S. Food and Drug Administration took action aimed at helping to ensure the safety and effectiveness of laboratory developed tests, or LDTs, which are used in a growing number of health care decisions and about which concerns have been raised…
Read More
May 1, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes AI Strategy

On 30 April, the MHRA published its strategy for artificial intelligence (AI). This sets out the MHRA's approach to AI as a regulator of AI products, and also the use of AI more broadly across the agency. This strategy is based on 5 principles encompassing safety, security and robustness; appropriate transparency and explainability; fairness, accountability and governance; and contestability and…
Read More
April 24, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA designates new UK Approved Body IVD devices and active implantable medical devices

The MHRA have increased their capacity to process conformity assessments for active implantable medical devices and IVD devices with the addition of LNE-GMED UK Limited 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 Medical Devices Regulations…
Read More
April 24, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 15 Apr)

Please note this is an extract of the original bulletin. UK-Singapore trade agreement documents Page summary: Decisions and other documents from the UK-Singapore trade agreement. Change made: ‘27 November 2023: UK-Singapore public stakeholders’ forum minute’ and ‘4 October 2023: UK-Singapore TSD board minute’ have been added to the page. Training on export control compliance Page summary: Courses, seminars, workshops and…
Read More
April 24, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Qserve free webinar: EU-IVDR two years on!

Qserve are hosting a free webinar on "EU-IVDR two years on!" where Sue Spencer will explain what the proposed extension of the IVDR means for manufacturers and how IVD manufacturers can understand and effectively use the IVDR transition for successful CE marking. This webinar aims manufacturers to help them by sharing the current state of play, what is the extension…
Read More
April 24, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 15 Apr)

Please note this is an extract of the original bulletin. DSIT cyber security newsletter – April 2024 Page summary: The April 2024 edition of the monthly DSIT cyber security newsletter. Change made: First published. Engineering Biology Sandbox Fund Page summary: This fund will support innovative engineering biology sandboxes which aim to accelerate pro-innovation regulatory reform and encourage business innovation and…
Read More
April 24, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 15 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…
Read More
April 24, 2024 in MedTech Europe Updates Regulatory Affairs Newsletter, MedTech Europe Updates Regulatory Affairs Newsletter Archive

MedTech Europe survey on eIFUs for IVDs (deadline: 17 May 2024)

MedTech Europe are conducting a survey for Europe based users of Near-Patient Testing devices (e.g. Medical Doctors, Physicians, Nursing staff, Operators, Pharmacy staff, Emergency Room staff, Ambulance staff) on the subject of electronic instructions for use (IFU) for Near-Patient Testing devices. This survey will provide invaluable insights into the practice in the healthcare field in the EU. Why are MedTech…
Read More
April 17, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Medical technology strategy: one year on Page summary: Achievements made since the launch of the medtech strategy and the next steps to boost the adoption of medical technology in the NHS. Change made: First published. Medical technology innovation classification framework Page summary: Outlines the aim, scope and definitions of the…
Read More
April 17, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Joint Statement on the UK-Australia Strategic Innovation Dialogue Page summary: Following the inaugural Strategic Innovation Dialogue in London, the UK and Australia have issued a Joint Statement. Change made: First published. Harmful international trade practices: guidance for business Page summary: How to identify and report harmful trade practices that affect…
Read More
April 17, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Weights & Biases: The AI Developer Platform Page summary: Weights & Biases provides an MLOps platform to help organisations gain auditable and explainable end-to-end machine learning workflows for reproducibility and governance. Change made: First published. RAI Institute: Artificial Intelligence Impact Assessment (AIIA) Page summary: A system-level AI Impact Assessment (AIIA),…
Read More
April 17, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

Publication of MDCG 2022-9 rev.1 Summary of safety and performance template

Directorate-General for Health and Food Safety has published the first revision of MDCG 2022 – 9: “MDCG 2022-9 rev.1 – Summary of safety and performance template”.  Members are requested to provide any comments to Regulatory@bivda.org.uk by 30 April.
Read More
April 17, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 Apr)

Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added Combined review of a CTIMP and Medical Device section and accompanying guidance Combined IMP Device guidance Borderlines…
Read More
April 17, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

Call for expertise on the development of IEC 61010-2-101

BSI are looking for experts 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), to join their committee EPL/66 in developing the above standard which is undergoing a revision. BIVDA members who may be interested in joining this committee are requested to contact Regulatory@bivda.org.uk.
Read More
April 10, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 01 Apr)

Please note this is an extract of the original bulletin. Government response to the Regulatory Horizons Council report on neurotechnology Page summary: Minister for Science, Research and Innovation and Minister of State for Health and Secondary Care have responded to recommendations made by the Regulatory Horizons Council on the regulation of neurotechnology. Change made: First published.        …
Read More
April 10, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 01 Apr)

Please note this is an extract of the original bulletin. UK & United States announce partnership on science of AI safety Page summary: The UK and US have signed a Memorandum of Understanding which will see them work together to develop tests for the most advanced AI models. Change made: First published. Collaboration on the safety of AI: UK-US memorandum…
Read More
April 10, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 01 Apr)

Please note this is an extract of the original bulletin. Trade with Canada Page summary: How you import from and export to Canada. Change made: Amendment to rules of origin sections on EU cumulation and origin quotas to reflect expiry of these time-limited clauses. Notice to exporters 2024/06: updates to UK strategic export list Page summary: The UK strategic export…
Read More
April 10, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 01 Apr)

Please note this is an extract of the original bulletin. MHRA Windsor Framework Page summary: New Guidance in accordance with the Windsor Framework Change made: First published. UK Parallel Import Licences Following Agreement of the Windsor Framework Page summary: On this page we provide information on UK Parallel Licences following the Agreement of the Windsor Framework. Change made: First published.
Read More
April 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 25 Mar)

Please note this is an extract of the original bulletin. UK-Switzerland enhanced free trade agreement negotiations Page summary: Documents relating to the UK and Switzerland’s negotiations for an enhanced trade agreement Change made: ‘Enhanced UK-Switzerland FTA negotiations: Update March 2024’ added to collection. Notices to exporters Page summary: Notices to exporters published by the Export Control Joint Unit (ECJU). Change made:…
Read More
April 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 25 Mar)

Please note this is an extract of the original bulletin. Regulation of devices in Northern Ireland Page summary: Information about the EU Regulations and their implementation in Northern Ireland Change made: Updated to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health…
Read More
April 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 25 Mar)

Please note this is an extract of the original bulletin. Responsible AI Toolkit Page summary: Toolkit for practitioners to support the responsible use of AI systems. Change made: First published. Research Ventures Catalyst: successful applications Page summary: Successful applications that will progress to the next stage of the Research Ventures Catalyst programme to stimulate the creation of novel research ventures.…
Read More
March 27, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 18 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…
Read More
March 27, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 18 Mar)

Please note this is an extract of the original bulletin. UK artificial intelligence sectoral analysis survey Page summary: Government research to understand the UK’s artificial intelligence sector, and how it is growing. Change made: Ipsos has been commissioned to carry out the survey fieldwork between mid-March and early May 2024. Cyber security longitudinal survey Page summary: An ongoing study looking…
Read More
March 27, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 18 Mar)

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: Page updated to reflect announcement of 2023 duty suspension window outcome. UK-Switzerland committee documents Page summary: Decisions, documents and meeting minutes from the Switzerland-UK…
Read More
March 21, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

European Commission publishes two implementing decisions on medical device harmonised standards

The European Commission have published two Implementing Decisions regarding medical device harmonised standards: "Implementing Decision (EU) 2024/815 of 6 March 2024 amending Implementing Decision (EU) 2021/1182 as regards harmonised standards for medical gloves for single use, biological evaluation of medical devices, sterilization of health care products, packaging for terminally sterilized medical devices and processing of health care products."This Implementing Decision…
Read More
March 21, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 11 Mar)

Please note this is an extract of the original bulletin. New action to tackle ethnic and other biases in medical devices Page summary: Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices. Change made: First published. MHRA response to Equity in Medical Devices: Independent Review Page summary: The MHRA welcomes the…
Read More
March 21, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 11 Mar)

Please note this is an extract of the original bulletin. DSIT cyber security newsletter – March 2024 Page summary: The March 2024 edition of the monthly DSIT cyber security newsletter. Change made: First published. Flexible AI Upskilling Fund Page summary: The Flexible AI Upskilling Fund pilot scheme will support small and medium-sized enterprises in the Professional and Business Services sector…
Read More
March 21, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 11 Mar)

Please note this is an extract of the original bulletin. Webinars for using the UKCA and CE markings to place products on the market in Great Britain and Northern Ireland Page summary: A list of upcoming webinars on the UK’s approach to product marking and placing products on the market in Great Britain and Northern Ireland. Change made: Webinar dates…
Read More
March 21, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 18 Mar)

Please note this is an extract of the original bulletin. Government response to the report of the equity in medical devices: independent review Page summary: Government’s response to the independent review into racial, ethnic and other factors leading to unfair biases in the design and use of medical devices. Change made: First published.        
Read More
March 12, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 11 Mar)

Please note this is an extract of the original bulletin. Equity in medical devices: independent review - final report Page summary: Findings and recommendations of the independent review into racial, ethnic and other factors leading to unfair biases in the design and use of medical devices. Change made: First published      
Read More
March 12, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 04 Mar)

Please note this is an extract of the original bulletin. Rubidium (Rb82) Generator approved as a diagnostic tool for people with heart disease Page summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has today (6 March 2024) approved the Rubidium (Rb82) Generator (RUBY-FILL) as a diagnostic tool for imaging of the heart, to evaluate blood flow and aid in…
Read More
March 12, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 04 Mar)

Please note this is an extract of the original bulletin. UK and Saudi Arabia unveil joint plan to put research links into top gear Page summary: UK and Saudi Arabia agree deal to boost research links, supporting work from food security to clean energy, to boosting business and R&D connections. Change made: First published. Engineering Biology Sandbox Fund Page summary:…
Read More
March 12, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 04 Mar)

Please note this is an extract of the original bulletin. Made Smarter Adoption research project Page summary: A report that summarises findings from a survey of beneficiary firms of Made Smarter Adoption. Change made: First published. Critical Minerals Task and Finish Group: government response Page summary: UK government response to the Task and Finish Group’s recommendations on industry resilience for…
Read More
March 6, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 26 Feb)

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 a link to ‘The Official Controls (Fees and Charges) (Amendment) Regulations 2024’.…
Read More
March 6, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 26 Feb)

Please note this is an extract of the original bulletin. UK-Canada AI safety researcher exchange programme Page summary: Competition for AI safety researchers in the UK or Canada to receive funding for logistical costs for a temporary exchange in the other country. Change made: First published. Biomanufacturing Fund (BMF): Phase 2 (closed to applications) Page summary: This fund is to…
Read More
March 6, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 26 Feb)

Please note this is an extract of the original bulletin. MHRA Chief Executive Dame June Raine to step down later this year Page summary: Dame June Raine, MHRA’s Chief Executive, will be stepping down in the Autumn following five years in the role Change made: First published. The Innovative Devices Access Pathway (IDAP) Page summary: The Innovative Devices Access Pathway…
Read More
March 6, 2024 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

NIST Releases Updated Cybersecurity Framework

The National Institute of Standards and Technology (NIST) is an agency of the US Department of Commerce whose mission is to promote innovation in America. The agency has updated the widely used Cybersecurity Framework (CSF), its landmark guidance document for reducing cybersecurity risk. The new 2.0 edition is designed for all audiences, industry sectors and organization types, from the smallest…
Read More
February 28, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 19 Feb)

Please note this is an extract of the original bulletin. Cyber security and economic growth: call for views Page summary: The McPartland Review of Cyber Security & Economic Growth is seeking views and evidence to inform its work. Change made: First published. UK Approach to Digital Standards: upholding integrity, accelerating innovation Page summary: Minister for Tech and the Digital Economy,…
Read More
February 28, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 19 Feb)

Please note this is an extract of the original bulletin. Trade Update: UK-Gulf Cooperation Council FTA negotiations Page summary: Statement on the sixth round of negotiations for a free trade agreement between the UK and the Gulf Cooperation Council Change made: First published. Business Basics Programme: final report Page summary: This report reviews the Business Basics Programme, what we have…
Read More
February 28, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 19 Feb)

Please note this is an extract of the original bulletin. Funding for game-changing tech which could destroy cancers and predict disease Page summary: Millions invested in eight innovative companies behind lifesaving new medical technology which could destroy liver cancer tumours, detect Alzheimer’s and quickly spot those at risk of stroke Change made: Changed to a more appropriate image    …
Read More
February 21, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. UK signs landmark economic partnership with Nigeria Page summary: Business and Trade Secretary visits Nigeria to sign a landmark UK-Nigeria economic partnership. Change made: First published. Webinars for using the UKCA marking and placing goods on the market in Great Britain and Northern Ireland Page summary: A list of upcoming…
Read More
February 21, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. UK and EU science chiefs urge British researchers and businesses work together with European colleagues through Horizon, and apply for grants to boost jobs, growth and scientific breakthroughs Page summary: European Commissioner for research joins UK Science and Technology Secretary to make joint commitment to maximising UK Horizon Europe success.…
Read More
February 21, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. Funding for game-changing tech which could destroy cancers and predict disease Page summary: Millions invested in eight innovative companies behind lifesaving new medical technology which could destroy liver cancer tumours, detect Alzheimer’s and quickly spot those at risk of stroke Change made: First published. Medical devices given exceptional use authorisations…
Read More
February 14, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Eight innovative technologies selected under IDAP pilot phase

MHRA launched Innovative Devices Access Pathway (IDAP) back in September 2023 to help streamline applications for innovative medical technologies. Today, MHRA have announced that eight innovative medical device technologies are selected for the IDAP. The eight selected innovative devices are: Blood test for Alzheimer’s disease: Roche Diagnostics Ltd has developed an Amyloid Plasma Panel which could help clinicians decide if…
Read More
February 14, 2024 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Health Canada: Draft guidance on how to interpret ‘significant change’ of a medical device

This guidance document has been updated to expand on the definition of "significant change" in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. Health Canada have a updated the Guidance on how to interpret ‘significant change’ of a medical device in order to expand…
Read More
February 14, 2024 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 the impact of the EU AI Act

BSI are hosting a webinar about updates on the EU AI Act progress, covering its history, the significant elements of the recent December deal, and its potential impact on various industries on 27 February. The webinar will include an explanation on EU AI Act and strategies to prepare for the Act's implementation. Members who are interested in attending this webinar…
Read More
February 14, 2024 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 12 Feb)

Please note this is an extract of the original bulletin. swissdamed – Swiss Database on Medical Devices The “going-live” date being deferred to the 2nd half of 2024
Read More
February 14, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 05 Feb)

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: The standard fee per application has changed to £240  
Read More
February 14, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 05 Feb)

Please note this is an extract of the original bulletin. Growth Gateway business advisory support Page summary: How African businesses can get tailored support to find trade and investment partners in the UK. Change made: First published. Good Work Plan: Proposals to support families Page summary: We’re seeking views on proposals to better support parents to balance work and family-life.…
Read More
February 14, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 05 Feb)

Please note this is an extract of the original bulletin. Unlocking the potential of quantum: £45 million investment to drive breakthroughs in brain scanners, navigation systems, and quantum computing Page summary: The government is today investing a total of £45 million in the UK’s quantum sector – as part of its commitment to transforming into a quantum-enabled economy by 2033…
Read More
February 14, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive, Upcoming Events Regulatory Affairs Newsletter, Upcoming Events Regulatory Affairs Newsletter Archive

Upcoming webinars

ISO 37001: How to prepare for the certification process ISO 37001 is an international standard on Anti-bribery management systems that allows organizations of all types to prevent, detect and address bribery. Speeki Pte Ltd are hosting a webinar about the the ISO 37001 certification process on 22 February. The webinar will include practical advice on preparing for a successful ISO…
Read More
February 7, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 29 Jan)

Please note this is an extract of the original bulletin. The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Provision) Regulations 2024 Page summary: The Instrument will implement the relabelling of Retained EU Law (REUL) (and related terms) as “assimilated law” (and related terms) in secondary legislation. Change made: First published. REUL (Revocation and Reform) Act 2023 statutory instruments…
Read More
February 7, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 29 Jan)

Please note this is an extract of the original bulletin. 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: Updated the details for LNE-GMED UK Limited, TUV SUD BABT Unlimited (0168) and Scarlet NB UK Ltd (8536) in the ‘UK approved bodies for medical…
Read More
February 7, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 29 Jan)

Please note this is an extract of the original bulletin. UK-Canada cooperation in AI compute: memorandum of understanding Page summary: Memorandum of Understanding (MoU) between the United Kingdom of Great Britain and Northern Ireland and Canada on AI compute. Change made: First published. Dual agreements cement UK-Canada science and innovation ties Page summary: A new agreement on AI compute, one…
Read More
February 7, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Foreign & Commonwealth Office weekly update (WC 29 Jan)

Please note this is an extract of the original bulletin. UK-China Intellectual Property Newsletter Page summary: At the end of every month we publish a newsletter covering recent intellectual property (IP) developments in China. Change made: Added China IP Newsletter (December 2023 - January 2024)
Read More
January 31, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Extension of CE mark recognition in Great Britain

On 01 August 2023, the Department for Business and Trade (DBT) announced their intention to recognise CE marking indefinitely beyond December 2024 for the 18 regulations falling under the DBT.  It does not include IVDs or medical devices. DBT have now announced that the UK Government intends to legislate the continued recognition of goods that meet the EU requirements, including…
Read More
January 31, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 22 Jan)

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: Banner added advising that government intends to legislate to continue recognition of EU requirements, including the CE marking, indefinitely for a range of…
Read More
January 31, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 22 Jan)

Please note this is an extract of the original bulletin. Cyber security breaches survey: ad hoc statistical releases Page summary: This page lists ad hoc statistical analyses on the Cyber Security Breaches Survey which have not been included in the main survey publications. Change made: First published. Government response on software resilience and security Page summary: The government’s response to…
Read More
January 31, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 22 Jan)

Please note this is an extract of the original bulletin. 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: The three PDFs for BSI Assurance UK Ltd have been updated. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have…
Read More
January 31, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

IP and Business Growth Survey 

Intellectual Property Office are inviting businesses to respond to our survey on IP and business growth. They are asking businesses to share their views on the role intellectual property plays in supporting the growth of their business. The survey is split into the following sections: Section 1 covers information about your business. You will be asked questions on your location,…
Read More
January 31, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Cabinet Office weekly update (WC 22 Jan)

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 the document: The Border Target Operating…
Read More
January 31, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 22 Jan)

Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) Page Summary: On January 26, 2024, the FDA held the second in a series of medical device sterilization town halls to: Describe the FDA’s early actions to help assure sterilization capacity in the U.S. and recent activities to reduce overall EtO reliance while maintaining…
Read More
January 24, 2024 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

European Commission publishes a proposal amending the EU MDR and EU IVDR

A proposal for amending Regulations (EU) 2017/745 (EU MDR) and (EU) 2017/746 (EU IVDR) has been published by the European Commission (EC) on 23 January. The European Commission propose a gradual roll-out of the European database on medical devices (EUDAMED), obligations in case of supply interruption, and transitional provisions for certain in vitro diagnostic medical devices (IVDs). This proposal includes:…
Read More
January 24, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added template for submitting Quarterly Summary Reports. Medical devices: UK approved bodies Page summary: UK approved bodies listed…
Read More
January 24, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Code on Genetic Testing and Insurance Page summary: The agreement between the government and the Association of British Insurers (ABI) on the use of genetic test results in underwriting insurance policies. Change made: First published. Code on Genetic Testing and Insurance: annual report 2023 Page summary: Annual report on agreement…
Read More
January 24, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. AI Safety Institute: overview Page summary: Find out about the AI Safety Institute. Change made: AI Safety Institute page added. Regulatory Horizons Council: Closing the Gap Series overview Page summary: RHC’s ‘Closing the Gap’ Series which aims to provide actionable insights and foster collaboration on solutions to address regulatory challenges.…
Read More
January 24, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 15 Jan)

Please note this is an extract of the original bulletin. Overseas business risk for Slovenia Page summary: Information on key security and political risks which UK businesses may face when operating in Slovenia. Change made: Information has been updated to provide the latest data, issued by the end of the 2023. UK takes action to boost supply chain resilience for…
Read More
January 24, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 15 Jan)

FDA and CMS issue joint statement on LDTs Laboratory developed tests, or LDTs, help physicians make critical decisions about their patients’ care. According to the Center for Disease Control and Prevention (CDC), approximately 70% of health care decisions depend on laboratory test results. Because of the important role of laboratory tests in health care decisions, it is essential to ensure…
Read More
January 24, 2024 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

BioMedical Alliance publishes a statement on shortage of diagnostic tests

The European BioMedical Alliance (36 leading European medical societies that together include more than 400,000 researchers and health professionals) along with the European Federation of Clinical Chemistry & Laboratory Medicine (EFLM) have published a Statement: “Urgent action needed to prevent widespread shortage of diagnostic tests”. This document points to the persisting problems with the implementation of EU IVDR. It calls…
Read More
January 17, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 08 Jan)

Please note this is an extract of the original bulletin. Conformity assessment and accreditation Page summary: Guidance for business and government departments. Change made: DBT and DHSC agreed joint policy statement added. Reference Documents for The Customs Tariff (Preferential Trade Arrangements) (EU Exit) Regulations 2020 Page summary: Find the UK’s preferential tariffs and Rules of Origin for the agreements contained…
Read More
January 17, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 08 Jan)

Please note this is an extract of the original bulletin. Implementation of medical devices future regime Page summary: The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices. Change made: Added ‘Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices’ and information about ‘future core regulations’. Regulatory…
Read More
January 17, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 08 Jan)

Please note this is an extract of the original bulletin. Turing Artificial Intelligence Fellowships Page summary: The Turing AI Fellowships are a £46 million initiative created by the UK government, aimed at attracting and maintaining the best talent in artificial intelligence. Change made: Two new Turing AI fellows – Professor Alison Noble and Professor Michael Bronstein were awarded Turing AI…
Read More
January 9, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA publishes a new MedTech roadmap

The MHRA have published a roadmap towards the future regulatory framework for medical devices. This sets out the relevant timelines into 2025. The roadmap intends to deliver greater international harmonisation, with more patient-centred, proportionate requirements for medical devices which are responsive to technological advances. According to the timelines, MHRA intends to run stakeholder discussions on the future core regulations during the…
Read More
January 9, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

NIHR i4i Real World Evidence Programme launched

The NIHR i4i Programme, in collaboration with the Office for Life Sciences (OLS) and the National Institute for Health and Care Excellence (NICE) are inviting applications to the Real World Evidence Programme. The Real World Evidence Programme is being led by OLS as part of the UK Government’s Life Sciences Vision and is backed by £10m of government funding. The…
Read More
January 9, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC review of the risk of modern slavery in the NHS supply chain

The Department of Health and Social Care published a review of the risk of modern slavery in the NHS on 14 December 2023. This was a commitment as part of the amendment to the Health and Social Care Act 2022 by the end of the year. The review was undertaken by NHS England and NHS Supply Chain Coordination Limited scrutinised…
Read More
January 9, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024* Page summary: In partnership with other global regulators, IRP is expected to further help bring life-saving new medicines to UK patients. Change made: First published. *Please note this update does not include medical and IVD devices. Unfettered Access…
Read More
January 9, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. New research into expansion of life-saving HIV testing programme Page summary: A new research project has been announced to evaluate an expansion of the hugely successful HIV opt-out testing programme to new sites across England. Change made: Updated 5 text references to 46 new hospitals, correcting to 47; amended ‘New…
Read More
January 9, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. The Retained EU Law (Revocation and Reform) Act 2023 (Consequential Amendment) Regulations 2023 Page summary: The Instrument will implement the relabelling of Retained EU Law (REUL) (and related terms) as “assimilated law” (and related terms) in primary legislation. Change made: Statutory Instrument sent to sift and Explanatory Memorandum sent to…
Read More
January 9, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. Digital identity certification for right to work, right to rent and criminal record checks Page summary: Guidance on how digital identity providers can become certified to complete digital identity checks for the ‘Right to Work’, ‘Right to Rent’ and DBS schemes. Change made: Links to some certification documents have been…
Read More
January 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. The Classification, Labelling and Packaging of Substances and Mixtures (Amendment and Consequential Provision) Regulations 2023 Page summary: This Statutory Instrument makes the necessary legislative amendments to update the statute book by removing references to the revoked Annex VIII of GB Classification, Labelling and Packaging of Substances and Mixtures Regulation. Change…
Read More
January 3, 2024 in Other Updates Regulatory Affairs Newsletter, Other Updates Regulatory Affairs Newsletter Archive

Swissmedic weekly update (WC 01 Jan)

Please note this is an extract of the original bulletin. Devices manufactured and used in healthcare institutions General information and notes on in-house devices according to MedDO and IvDO 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…
Read More
January 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

UK HSA weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. Committees on Toxicity, Mutagenicity, Carcinogenicity of Chemicals in Food, Consumer Products and the Environment: joint annual report Page summary: Joint annual report includes brief toxicological background to the Committees’ decisions; discussion summaries; Committees’ published statements. Change made: Added 2022 joint annual report.
Read More
January 3, 2024 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

FDA publishes a new draft guidance on 510(k) Third Party Review Program

The US FDA have published 510(k) Third Party Review Program and Third Party Emergency Use Authorization (EUA) Review Draft Guidance for Industry, Food and Drug Administration Staff, and Third Party Review Organizations This draft guidance outlines FDA's current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by…
Read More
January 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 18 Dec)

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 recording of ‘MHRA International Recognition Webinar November 2023’. *Please note this update does not include medical and IVD devices. Notify the MHRA about a clinical investigation for a medical device Page summary:…
Read More
January 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

New MHRA monthly newsletter

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. Subscribe to their new monthly newsletter to stay informed on what is going on at the MHRA. MHRA Newsletter December 2023 Please note this is an extract of the original bulletin. Clinical Trials and Investigations Performance The latest MHRA performance data shows…
Read More
January 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 18 Dec)

Please note this is an extract of the original bulletin. Joint outcome statement: UK-India round thirteen of FTA negotiations Page summary: Round thirteen of negotiations for a free trade agreement between the United Kingdom and the Republic of India Change made: First published. First UK Trade Mission to Kyiv Boosts Defence Cooperation Page summary: UK Government and UK defence industry…
Read More
January 3, 2024 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 18 Dec)

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: Made: 18 December 2023 replaced Laid before Parliament: 7 November 2023. UK-Japan science and innovation funding opportunities Page…
Read More
January 3, 2024 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

New available International Standards on Artificial Intelligence

CEN and CENELEC identifies and adopts two international standards on Artificial Intelligence: ISO/IEC/TR 24027:2023 - Information technology - Artificial intelligence (AI) - Bias in AI systems and AI aided decision making and ISO/IEC TR 24029-1:2021 - Artificial Intelligence (AI) - Assessment of the robustness of neural networks - Part 1: Overview. These standards are available from 20 December.
Read More
December 20, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 11 Dec)

Please note this is an extract of the original bulletin. Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety Page summary: The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. Change made: Published Executive summary of consultation and recommendations. COVID-19 test validation approved…
Read More
December 20, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 11 Dec)

Please note this is an extract of the original bulletin. Advai: Regulatory Aligned AI Deployment Framework  Page summary: Case study from Advai. Change made: First published. Advai: Implementing a Risk-Driven AI Regulatory Compliance Framework Page summary: Case study from Advai. Change made: First published. Advai: Assurance of Computer Vision AI in the Security Industry Page summary: Case study from Advai.…
Read More
December 20, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 11 Dec)

Please note this is an extract of the original bulletin. New unit to crack down on firms dodging Russian sanctions Page summary: Government announces new unit to clamp down on companies evading sanctions Change made: First published. Reference Documents for The Customs Tariff (Preferential Trade Arrangements) (EU Exit) Regulations 2020 Page summary: Find the UK’s preferential tariffs and Rules of…
Read More
December 20, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

UL Standards update (WC 30 Nov)

UL have published the following documents between 30 November and 15 December: Standard UL 2900-1 Ed. 2 Software Cybersecurity for Network-Connectable Products, Part 1: General Requirements CSDS Proposal UL 62133-2 Ed. 1 Secondary Cells and Batteries Containing Alkaline or Other Non-Acid Electrolytes - Safety Requirements for Portable Sealed Secondary Cells, and for Batteries Made from Them, for Use in Portable…
Read More
December 20, 2023 in FDA updates Regulatory Affairs Newsletter, FDA Updates Regulatory Affairs Newsletter Archive

U.S. FDA weekly update (WC 18 Dec)

FDA publishes a draft guidance on Real World evidence FDA is issuing this draft guidance to clarify how FDA evaluates real-world data (RWD) to determine whether they are of sufficient quality for generating real-world evidence (RWE) that can be used in FDA regulatory decision-making for medical devices. This draft guidance also proposes expanded recommendations to the 2017 guidance, Use of Real-World…
Read More
December 20, 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

ISO 13485 Stakeholder Feedback 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…
Read More
December 15, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 04 Dec)

Please note this is an extract of the original bulletin. Advanced manufacturing plan Page summary: The advanced manufacturing plan sets out the actions we are taking to be the best place in the world to start and grow a manufacturing business. Change made: HTML version of the Advanced Manufacturing Plan added to document list. Time updated: 11:47am, 6 December 2023…
Read More
December 15, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 04 Dec)

Please note this is an extract of the original bulletin. Landmark moment for scientists, researchers and businesses as UK association to £80 billion Horizon research programme officially sealed Page summary: The UK’s association to the world-leading Horizon and Copernicus programmes has been officially sealed today (Monday 4 December), as Science and Technology Secretary Michelle Donelan visits Brussels to turbo-charge efforts…
Read More
December 15, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 04 Dec)

Please note this is an extract of the original bulletin. Government response to the review into commercial clinical trials Page summary: The full government response to the Lord O’Shaughnessy independent review of UK commercial clinical trials. Change made: Added Welsh version. New research into expansion of life-saving HIV testing programme Page summary: A new research project has been announced to…
Read More
December 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DBT weekly update (WC 27 Nov)

Please note this is an extract of the original bulletin. Advanced manufacturing plan Page summary: The advanced manufacturing plan sets out the actions we are taking to be the best place in the world to start and grow a manufacturing business. Change made: First published. UK battery strategy Page summary: The UK battery strategy sets out the government’s vision for…
Read More
December 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DSIT weekly update (WC 27 Nov)

Please note this is an extract of the original bulletin. Data Protection and Digital Information Bill: supporting documents Page summary: Supporting documents assessing the impact of the Data Protection and Digital Information Bill. Change made: Added the DWP third party data impact assessment to the list of supporting documentation. Research and Innovation Organisations Infrastructure Fund Page summary: Fund for improving…
Read More
December 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

MHRA weekly update (WC 27 Nov)

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: Clarification concerning fees and actions required to change legislation of a registered device. The…
Read More
December 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

DHSC weekly update (WC 27 Nov)

Please note this is an extract of the original bulletin. New research into expansion of life-saving HIV testing programme Page summary: A new research project has been announced to evaluate an expansion of the hugely successful HIV opt-out testing programme to new sites across England. Change made: Added a list of hospitals covered by the extension of the HIV opt-out…
Read More
December 8, 2023 in European Commission Updates Regulatory Affairs Newsletter, European Commission Updates Regulatory Affairs Newsletter Archive

European Commission study on availability of medical devices on the EU market

European Commission’s Directorate-General for Health and Food Safety (DG SANTE) has contracted Austrian National Public Health Institute (Gesundheit Österreich GmbH / GÖG) to launch a study for manufacturers of medical devices and in-vitro diagnostics and authorized representatives. The aim of the study is to collect information on the transition of devices to medical devices and in-vitro diagnostic medical devices regulations.…
Read More
December 8, 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

New EU Reference Labs designated for Class D IVD devices

The European Commission have designated five EU reference laboratories for high-risk in vitro diagnostic medical devices (IVDs) under Regulation (EU) 2023/2713. These labs will enhance conformity assessments and advisory tasks for devices related to critical health areas like hepatitis, retroviruses, bacterial agents and life-threatening respiratory viruses. The labs are expected to start testing IVDs from October 1, 2024, for tasks…
Read More
December 8, 2023 in UK Government Updates Regulatory Affairs Newsletter, UK Government Updates Regulatory Affairs Newsletter Archive

Draft statutory instrument published in respect of Northern Ireland

The Department of Health and Social Care have laid a new draft statutory instrument before the House of Commons and the House of Lords on 14 November. Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2023 (SI 2023) makes provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament. BIVDA have provided…
Read More
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…
Read More
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:…
Read More
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…
Read More
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…
Read More
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.
Read More
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.  
Read More
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…
Read More
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…
Read More
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.…
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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).…
Read More
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…
Read More
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…
Read More
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…
Read More
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.…
Read More
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…
Read More
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…
Read More
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):…
Read More
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)
Read More
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…
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.…
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.  
Read More
October 13, 2023 in Industry Newsletters Regulatory Affairs Newsletter, Industry Newsletters Regulatory Affairs Newsletter Archive

Share Your Expertise

CLSI Volunteer Opportunities for Standards Development
Read More
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…
Read More
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  
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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.
Read More
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.
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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:…
Read More
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…
Read More
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…
Read More
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.…
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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.  
Read More
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…
Read More
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.
Read More
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…
Read More
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.…
Read More
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…
Read More
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.…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.…
Read More
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…
Read More
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…
Read More
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.  
Read More
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…
Read More
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…
Read More
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.  
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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:…
Read More
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…
Read More
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.
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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…
Read More
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.
Read More