EU REP · EC REP · MDR Article 11
EU Authorised Representative for Medical Device Manufacturers
Germany-based regulatory representation for medical device manufacturers established outside the European Union.
When is an EU Authorised Representative required?
Medical device manufacturers established outside the European Union require an EU-established Authorised Representative for devices placed on the Union market where the MDR requires such representation.
The written mandate
The relationship between manufacturer and Authorised Representative is defined through a written mandate that sets out the applicable regulatory responsibilities.
Typical EU REP responsibilities
- Verification of relevant conformity documentation.
- Availability of required documents to competent authorities.
- Support for applicable registration obligations.
- Communication with competent authorities.
- Cooperation regarding corrective or preventive actions.
- Forwarding relevant complaints and suspected incident information.
EU REP, EC REP and Authorised Representative
EC REP and EU REP are commonly used industry terms. The regulatory function itself is the Authorised Representative role defined by the European medical device framework.