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

Article preview from "The Gray Sheet" - October 1, 2012

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.

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

Article preview from "The Gray Sheet" - October 1, 2012

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. 26 to make large-scale revisions to the highly decentralized regulatory system for devices and diagnostics sold in the 32-country region.

Despite steering clear of a centralized government approval process for devices, the proposal includes one provision that companies worry will bring the EU closer to such a system and unnecessarily delay product marketing. Specifically, the Commission wants a new “scrutiny mechanism,” where a cross-continent Medical Device Coordination Group would have the option to review third-party pre-market assessment reports for select devices before the products go to market.

Eucomed, the European device industry trade group, had anticipated the scrutiny proposal and warned against it earlier this month. Now the group will advocate for its removal as the Commission’s plan is considered by the EU's two legislative bodies, the European Parliament and the European Council. Eucomed will also need to dissuade legislators who believe the EU requires an even stronger pre-market review process than proposed by the Commission in response to recent product safety controversies in the region.

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