Proposal To Amend MDR/IVDR May Pass ‘Final Step’ Before Adoption Next Week
Amendments to support the implementation of the MDR and IVDR have appeared as provisional items on the agenda of a 7 March Council of the EU meeting, marking a potential final step before formal adoption.
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Implementing The EU MDR Amendment: “Messy” And “A Lot To Figure Out On The Hoof”
The EU Medical Device Regulation amending regulation is not some kind of “bail-out or blanket extension” for manufacturers, medtech expert lawyer Erik Vollebregt warns. But it offers valuable opportunities to already-prepared manufacturers.
EU Gives Final Thumbs Up To Altering Transition Deadlines For MDR Legacy Products
EU institutions have unanimously agreed to amendments to support the implementation of the Medical Device Regulation. The speed at which this has been done reflects the urgency of new measures to address the EU’s crisis.
EU Regulatory Roundup, May 2023: MDR Extension Updates Resume
May saw a resurgence of EU MDR news, following a few quieter weeks. Guidance on demonstrating compliance with extended transition periods and compiling clinical investigation reports were among the top-read articles in Medtech Insight in the past month.