Medical Device EU Authorized Representative
EU Medical Device Regulation (EU MDR) mandates appointment of Authorized Representative for non-EU based manufacturers of medical device that wants to place their device on the EU market. We provide the following EU Authorized Representative services to non-EU based medical device manufacturers:
• Review and retention of technical documentation
• EUDAMED requirements compliance and periodic data accuracy review
• Support management of EU device vigilance & reporting system
• Point of contact for the Competent Authority