Compromise Sought On Device Reform Proposal In European Parliament Committee

Article preview from "The Gray Sheet" - June 03, 2013

 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.

Compromise Sought On Device Reform Proposal In European Parliament Committee

Article preview from "The Gray Sheet" - June 03, 2013

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 medical device reform legislation in the Environment, Public Health, and Food Safety Committee.

The committee met May 29 to debate amendments to Roth-Behrendt’s legislative proposal, released last month. The rapporteur’s report was intended to modify a reform plan issued last year by the European Commission, the executive branch of the EU government.

Roth-Behrendt’s plan would establish a centralized EU-wide pre-market review process for “innovative” high-risk devices and a decentralized review process, run by individual member state governments, for follow-on high-risk products. Her proposal goes much further than the European Commission’s recommendations. The commission plan would create a new centralized EU Medical Device Coordination Group with authority to review notified bodies’ conformity assessments for certain high-risk products, but its recommendations would be nonbinding.

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