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Compromise Sought On Device Reform Proposal In European Parliament Committee

Dagmar Roth-Behrendt, the legislator shepherding medical device reform legislation in the European Parliament, says she wants to work with the European Commission to establish a heightened market-access standard for high-risk devices, even if it falls short of her proposal for a full PMA-like review.

The leading legislator on a bill in the European Parliament to reform medical device oversight signaled she was willing to compromise on her proposal to establish a full-fledged PMA-like review in Europe for high-risk devices during a May 29 committee hearing.

“I deeply hope we can find compromises,” said Dagmar Roth-Behrendt, a parliamentarian from Germany and the designated rapporteur for the...

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