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Implementing The EU MDR Amendment: “Messy” And “A Lot To Figure Out On The Hoof”

 
• By Amanda Maxwell

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.

Implementation
• Source: Shutterstock

The EU medtech sector now awaits the publication of the new EU Medical Device Regulation amendment, and extended transition timelines for legacy products as well as an understanding of the fall-out of the new measures. This follows final adoption of the document in the EU Parliament on 16 February.

Given the speed at which the document, intended to take pressure off notified bodies and stem the flow of products leaving the market, was adopted by the EU institutions, and given the length and complexity of the amendments, there are numerous questions over how

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More from Geography

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• By Brian Bossetta

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