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 KempJune 18, 2025
Dear members, Please see below MedTech Europe Update on the EU proposed classification of Trifluoroacetic Acid (TFA) – the proposal is as below, and then MedTech Europe's response based on feedback received from the sector. ECHA consultation on the proposed CLH updated classification of Trifluoroacetic Acid (TFA). Background: The German authorities (BAuA) have put forward this proposal, to update the…
Ben KempJune 18, 2025
An update from Taylor Wessing on international patents and the United Patent Court decisions, and approach: Synapse | Two years of UPC patent litigation
Ben KempJune 18, 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 KempJune 18, 2025
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 KempJune 18, 2025
Upcoming EU active substance renewal submission deadlines Apply for active substance renewal by the deadlines to keep products on the NI market. Under the EU Biocidal Products Regulation (EU BPR), active substance approvals will expire unless a renewal application is submitted to ECHA at least 550 days before their expiry date. The 550-day deadlines are coming up for the following…
Ben KempJune 18, 2025
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 KempJune 18, 2025
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 KempJune 18, 2025
NHS red tape blitz delivers game-changing new cancer treatment Page summary: Patients to benefit from new era in cancer treatment, as Government slashes red tape to unleash life-saving innovation Change made: First published. Time updated: 4:09pm, 10 June 2025 Our vision for a new model of NHS care Page summary: The Health and Social Care Secretary spoke at NHS ConfedExpo…
Ben KempJune 18, 2025