EC REP responsibilities

The term "European Authorised Representative" refers to a natural or legal person located within the European Union who has been granted a written mandate by a non-EU manufacturer. This mandate empowers them to act on behalf of the manufacturer in carrying out specified tasks in accordance with the Medical Device Regulation (MDR) or In Vitro Diagnostic Medical Device Regulation (IVDR). Authorised Representatives play a crucial role in ensuring device compliance and serve as the primary point of contact for European authorities and Notified Bodies. Their involvement is instrumental in upholding regulatory requirements and facilitating smooth communication between manufacturers and regulatory entities within the European Union.

MDR and IVDR outline the delegated tasks and conditions for the manufacturer's authorised representative. A clear and precise mandate between the EC REP and the manufacturer should cover this relationship. The authorised representative carries out the tasks specified in the mandate and must provide a copy to the competent authority upon request.

The Authorised Representative assumes joint liability with the manufacturer for any issues pertaining to defective medical devices. This includes taking responsibility for cases of noncompliance or incompliance on the part of the manufacturer.