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.
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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.
Fulfilling performance evaluation obligations under the EU In Vitro Diagnostics Regulation can be confusing for manufacturers and particularly SMEs. Trade body MedTech Europe explains why defining the intended purpose of a product is a good place to start.
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.