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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.

The Commission, which serves as the executive branch of the European Union government, issued proposed legislation Sept

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