Industry, Notified Bodies Reject EMEA Oversight of Devices

Stakeholders said no to a European Commission proposal to expand the role of the European Medicines Agency (EMEA) to include medical devices, claiming it would delay introduction of new technologies and impose heavy costs on small devicemakers. The proposal to enlarge the EMEA’s role was one option floated by the commission last spring in a public consultation on recasting the legal framework for devices.
International Medical Device Regulatory Monitor