EU & UK Cosmetics & Medical Device Representation

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

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