03.02.2012 – Guidance on EU Authorised Representatives published

03.02.2012 – Guidance on EU Authorised Representatives published

The European Commission has published MEDDEV 2.5/10 ‘Guideline for Authorised Representatives’ on its website following approval and adoption at the recent Medical Device Experts Group (MDEG) meeting.

The document is the result of extensive cooperation between the EAAR membership, the Commission, and representatives of member states within both the MDEG and the Compliance and Enforcement Group (COEN).

The document establishes clear guidelines on various aspects of the relationship between manufacturers and their Authorised Representative (AR) and includes a note of the expectations that member state competent authorities have with regard to the professionalism and conduct of ARs. It also addresses what should be the minimum content of agreements between manufacturers and ARs.