European Authorized Representative

AR or EC Rep

All non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) in the European Community Market. As Authorized Representative, CEpartner4U is your interface with the EU Competent Authorities.

CEpartner4U Authorized Representative services:

  • Manufacturer’s legal representation under the applicable medical device directive in Europe and CEpartner4U name and address on product labels.
  • Verification of the EC Declaration of Conformity
  • Registration of devices with the Competent Authorities, as required under the applicable directives
  • Responding to requests of Authorities
  • Providing technical documentation to Competent Authorities, on their request
  • Forwarding copies of all written requests, notifications and/or orders of the competent authorities and/or notified bodies and/or third parties to the extent they contain information relating to the product(s)
  • Informing the manufacturer about amendments to the applicable Directive
  • Performing an annual surveillance review covering the status of the technical documentation.
  • Submitting to the Competent Authorities manufacturer’s reports on incidents in accordance with the medical devices vigilance system.
  • Informing the manufacturer about remedies available under the law of the European Union in case of events that restrict the manufacturer with the free movement of his products in the EU
  • Arranging for Certificates of Free Sale
  • Respond to ad hoc questions (fair use policy)

CEpartner4U FAQ Authorized Representative (PDF) >