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EU Device Reform Proposal Adds More Government Scrutiny, But No FDA-Like Review Body

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.

The European Commission’s proposal to reform the oversight of medical devices and diagnostics does not envision a pre-market approval agency akin to FDA as some had feared, but it would clearly increase the role of government in the process and slow launches for some products.

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