AR/EC Rep

European Authorized Representative

To place a medical device on the European Market, all non-EU manufacturers must appoint an Authorized Representative (AR or EC Rep) within the Union.
As Authorized Representative, CEpartner4U is your interface with the EU Competent Authorities.

CEpartner4U Authorized Representative services:

  • As mandated by the manufacturer (contact CEpartner4U for details);
  • Manufacturer’s legal representation under the Medical Device Regulations and CEpartner4U’s name and address on product labels;
  • Verification of the EC Declaration of Conformity;
  • Registration of devices as required under the Regulations and the manufacturer’s mandate;
  • Responding to requests from Authorities;
  • Providing technical documentation to Competent Authorities, upon request;
  • Forwarding copies of all written requests and/or notifications of the competent authorities, notified bodies, and third parties to the manufacturer, given they contain information relating to the product(s);
  • Informing the manufacturer about amendments to the Regulations;
  • Performing an annual surveillance review 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 of countermeasures in case the free movement of its device on the European Market is compromised;
  • Arranging for Certificates of Free Sale;
  • Respond to ad hoc questions (fair use policy);
  • Access to CEpartner4U templates and forms, supporting the Technical Documentation and Quality Management System;
  • The manufacturer’s documents, certificates and project related files are stored on a secure, ISO27001 certified data center located in the Netherlands, accessible only to personnel working on its project. The manufacturer’s data is never stored on laptops, desktop computers or portable media. We provide remote access as well as up- and download of large amounts of data;
  • CEpartner4U holds in strict confidence and never discloses, provides, communicates, or makes accessible to any person or use in any way for CEpartner4U’s own or another’s benefit any confidential information.

 

FAQ AR/EC Rep >