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...
30 Oct, 2024 Further revisions to the MDR and IVDR By Alex Denoon Last week, the European Parliament (EP) passed a resolution calling on the European Commission (EC) to further revise the Medica Devices...
07 Oct, 2024 Incoming: MHRA consultation on UK Medical Devices Regulations By Hugo Kent-Egan Alex Denoon On 25 September 2024, the MHRA updated its roll-out of the new medical device regulatory framework for Great Britain. The MHRA aims to...
02 Oct, 2024 TEAM-NB’s interpretation of “Structured Dialogue” between Manufacturer and Notified Body, clarifies little By Alex Denoon Anna Hall TEAM-NB has published a new version (v5.0) of its Code of Conduct for Notified Bodies. While we don’t normally comment on this Code,...