25 Nov, 2024 UK MDR consultation – proposals for International Reliance on medical device approvals By Jamie Hatzel The consultation on the future of the UK’s Medical Devices Regulations 2002 (UK MDR), initiated by the MHRA on 14 November 2024,...
25 Nov, 2024 Shaping the future of medical devices: MHRA proposes four key changes to regulations By Alex Denoon Anna Hall Background The MHRA has launched a Consultation on future changes to the UK Medical Devices Regulations. The consultation addresses four...
29 Jan, 2024 Implementation deadlines for the EU In Vitro Diagnostic Medical Device Regulation further postponed By Alex Denoon Melissa Dix Extending the transitional periods for implementation A considerable number of in vitro diagnostic medical devices (IVDs) currently on...
28 Jul, 2023 New UK post-market surveillance rules for medical devices released By Jamie Hatzel The UK government recently released the text of a new draft statutory instrument (SI) which will update the post-market surveillance...