European Parliament Committee Proposes Enhanced Device Reg Reforms
This article was originally published in The Gray Sheet
The Internal Market and Consumer Protection Committee approved amendments to the EU Commission’s proposal. The package includes tougher pre-market regulation and more stringent scrutiny of notified bodies compared to what the Commission floated last year.
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Members of the committee appeared split on the question of centralized pre-market authorization during an April 24 debate, but generally supported other proposals in a committee report issued earlier this month.
A key legislator on device reform in the European Parliament has issued a strong call to establish pre-market authorization for high-risk devices in Europe, among other consequential regulatory changes.
The recommendation attracting the most concern from industry: a new Medical Device Coordination Group that would have the option to scrutinize third-party pre-market assessment reports for select devices prior to marketing.