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European Authorized Representative (EC REP) Services


European Authorized Representative (EC REP) Services - Overview

Foreign Medical Device manufacturers who do not have a physical location in Europe must appoint a European Authorized Representative (EAR) based in any member countries of the European Union, who are a part of the countries recognizing CE mark. At Freyr, we offer exceptional European Authorized Representative Services (EC REP) to support our clients at every step in their device registration process.

A European Authorized Representative (EAR) serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with EU MDR (2017/745) and/or IVDR (2017/746). They act as a point of contact between the non-EU manufacturer and the notified body, as well as national competent authorities.

In addition, the European Authorized Representative (EC REP) Services include:

  • Device registration with national competent authority
  • Verify manufacturer’s Declaration of Conformity (DoC), technical documentation and CE Certificate
  • Ensuring that an appropriate conformity assessment procedure has been carried out
  • Keep available the copy of the Technical File, DoC and CE certificate including the supplements and amendments as applicable
  • Communication with the EU competent authorities when required
  • Confirming that Technical File Documentation is available for 10 years (Medical Devices) and 15 years (implantable devices) after the last device is placed in the market
  • Support in incident and Field Safety Corrective Action (FSCA) reporting
  • Represent the non-EU manufacturer in the EU,  has its name and address on product labelling and other Regulatory documents
Freyr Expertise and Advantages

Freyr Expertise

  • Independent representation and Regulatory support
  • Continuous liaison with agency for submissions, queries and feedback
  • Single point of contact in the country for liaison with Regulatory agency

Freyr Advantages

  • Cost-effective annual support for EC REP services
  • Ensured Regulatory expertise outlook
  • Qualified team of experts with hands-on experience across all categories of Medical Devices
  • Support for region specific Regulatory complexities
  • Extensive partner network across the member countries