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.
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MDR Amending Regulation Officially Published And Already In Force
The deadlines for legacy products under the Medical Device Regulation have changed. Here are the essentials that all medtech players need to understand in how the MDR has now been amended.
EU Council Adopts MDR/IVDR Amendment Proposal
The EU Council has adopted proposed changes to the EU Medical Device Regulation that will see transition deadlines extended for legacy devices. This completed final legislative step means that the amendments are set to enter force in around a week’s time, on 15 March.
MedTech Europe IVDR Impact Report: The Good, The Bad And The Ugly
The outcome of a survey by trade association MedTech Europe shows that while more than 90% of companies benefited from the extension of IVDR transition deadlines, significant issues remain that could see many diagnostics disappear from the market.