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European Authorized Representative (EC REP)

Overview

Overview

Foreign Medical Device manufacturers who do not have a physical location in Europe must appoint a European Authorised Representative (also referred as EC REP or EAR) based in any member countries of the European Union, who are a part of the countries recognizing CE mark.

An EU Authorized Representative serves as a legal entity designated by non-European Union (EU) manufacturers, to represent them in the EU and ensure their compliance with the European Directives. 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 services include:

  • Device registration with the national competent authority
  • Review manufacturer’s Declaration of Conformity (DoC) and CE Certificate
  • Confirm updated Technical File with the manufacturer
  • Ensuring that an appropriate conformity assessment procedure has been carried out
  • 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
  • Identified on product labeling and other Regulatory documents
Freyr Expertise and Advantages
Expertise

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
Advantages

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