Overview

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

An European Union 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 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 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