How the New Medical Device Regulation is Shaping Europe

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ARTICLE SUMMARY:

After years of anticipation and delays, the new EU Medical Device Regulation has finally become effective, turning discussions of regulatory changes from hypothetical to reality. Yet, many questions and uncertainties still remain for product companies and regulators. Our discussion with Serge Bernasconi, CEO of MedTech Europe, highlights both the knowns and the still unknowns, with, not surprisingly, the latter far outnumbering the former.

After all the years leading up to the implementation of the new EU Medical Device Regulation (MDR) on May 26, 2021, it is fair to assume that regulators and industry would have worked out most of the basics of the new rules in advance of launching the new regimen, especially given the added year delay due to the pandemic. Yet, as you’ll see in this conversation with Serge Bernasconi, CEO of MedTech Europe, the medical device industry trade association, it appears that nothing could be further from the

truth and that there actually are more questions than answers for both product companies and regulators concerning MDR.

The good news, according to Bernasconi, is that most medtech companies appear to have used the lead-up time wisely, preparing to operate under the new standards and thereby avoiding what could have been one major bottleneck. The flip side of that preparation is the myriad questions that remain unanswered.

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