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Explore the New CLSI EP46 and EP21 Standards

NEW — CLSI EP46 Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures   CLSI EP46 provides models and approaches for setting allowable total error (ATE) goals and limits, helping developers and laboratories define acceptance criteria for quantitative test methods.   This essential resource covers: Approaches for determining ATE based on clinical outcomes, biological variation, and…
Ben Kemp
June 26, 2025
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MDR/IVDR Targeted Evaluation – Final summary report published

  The European Commission has published the Final Summary Report of its Targeted Evaluation of the EU Medical Devices and In Vitro Diagnostic Regulations (MDR/IVDR). Early analysis by MedTech Europe has shown the following: Reforms should prioritise simplification, a risk-based and proportionate approach, and clearer guidance to enhance implementation. There is support for harmonised EU regulations; however, compliance costs remain…
Ben Kemp
June 24, 2025
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MHRA Airlock round 2 open until 14 July

Applications for the second round of the MHRA AI Airlock programme have opened following a successful pilot phase. The first round saw four breakthrough AI technologies, including software that could help doctors create personalised cancer treatment plans, and a tool to help hospitals, AI developers, and regulators monitor AI performance in real time, tested in a regulatory ‘sandbox’ environment. Similar…
Ben Kemp
June 23, 2025
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For information: OSOA provisional agreement reached by Council/Parliament

Dear members, MedTech Europe update on the EU progress with the proposed One Substance One Assessment (OSOA) legislation. Dear members, I hope you are all well. We are writing to update you on the latest developments on the ‘One Substance, One Assessment’ (OSOA) package of legislative proposals, including targeted amendments to MDR, RoHS, and the proposal for a new chemicals…
Ben Kemp
June 18, 2025
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MDCG 2025-4 – Guidance on the safe making available of medical device software (MDSW) apps on online platforms (June 2025)

Dear members, please see the new MDCG guidance regarding making available Medical Device Software, the guidance includes IVD software in scope. Note that this will also include provision of software via online platforms to Northern Ireland, as EU IVD Regulation also applies to Northern Ireland. MDCG 2025-4 - Guidance on the safe making available of medical device software (MDSW) apps…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

New medical devices Post-market Surveillance regulations in force

New medical devices Post-market Surveillance regulations in force From today, new legal requirements for monitoring the safety of medical devices take effect, as part of our broader transformation of the UK’s medical device regulatory framework. The new Post-Market Surveillance (PMS) regulation is the first major overhaul of medical device regulation across Great Britain. Today’s reform applies to all UKCA- and…
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

Field safety notices: guidance for manufacturers

Field safety notices: guidance for manufacturers Page summary: How to write clear and effective field safety notices (FSNs) for medical devices. Change made: Updated to reflect the coming into force of The Medical Devices (Post-market Surveillance requirements) (Amendment) Regulations 2024. Time updated: 10:00am, 16 June 2025
Ben Kemp
June 18, 2025
Regulatory Affairs NewsletterRegulatory Affairs Newsletter ArchiveUK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA Updates (WC 16 June)

Borderline products: medical devices and other products Page summary: How the MHRA makes decisions on whether a borderline product is a medical device and whether medical devices regulations should apply. Change made: Removal of paragraph 20. In-house manufacturing from the Borderlines page. This content is superseded on other published guidance pages. Time updated: 9:35am, 9 June 2025 Medical devices given…
Ben Kemp
June 18, 2025
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