European Commission Circulates Interim Proposals to Prepare for MDD Revisions

Two draft proposals intended to help European devicemakers and notified bodies prepare for the transition from three medical device directives (MDD) to two major regulations are beginning to circulate prior to the European Commission’s (EC) expected release of the draft regulations on Sept. 26, an expert says. The drafts include an EC “recommendation” on how notified bodies should conduct audits of device manufacturers and a proposed regulation on how notified bodies should be designated and supervised by EU member states, said Gert Bos, head of regulatory and clinical affairs of medical devices at the British Standards Institution.
International Medical Device Regulatory Monitor