International News In Brief
This article was originally published in The Gray Sheet
Executive Summary
In wake of PIP breast implant scandal, a European Parliament committee calls for stronger device laws. More international regulatory news.
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Pre-Market Question Attracts Debate At EU Parliament Session On Device Reforms
The Committee held a workshop Feb. 26 to address a proposal issued last year by the European Commission to impose reforms on EU device oversight. Some members of Parliament and others in Europe believe the proposal may not go far enough when it comes to pre-market oversight.
Europe Device Reg Reform Proposal: More Scrutiny Of Notified Bodies Expected
Industry expects the European Commission to propose more oversight of notified-body reviews by member countries. But the Commission appears to have resisted calls to establish a direct government approval process for devices.
International News In Brief
Regulatory and innovation news from around the world.