The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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