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.
You may also be interested in...
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.
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.
What is the importance of medtech in diagnosing and treating rare diseases? This is among the key questions that an international working group aims to address through a collection of articles in the Orphanet Journal of Rare Diseases.