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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.

European policymakers have for the past four years been weighing options on how to reform their regulatory system for medical devices and diagnostics. The European Commission will issue its proposal Sept. 26.

The Commission, the executive branch of the European Union government, has signaled that its upcoming proposed legislative rules will seek to strengthen the current decentralized oversight approach for devices, rather than replace it

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