Authorised representatives in EUDAMED
Look up medical device manufacturers, authorised representatives, importers, and system producers registered across the EU.
An authorised representative acts within the EEA on behalf of a manufacturer based outside the EEA.
1001 Authorised representatives in EUDAMED
Role and obligations in EUDAMED
An authorised representative is an entity established in the European Economic Area that a manufacturer based outside the EEA appoints to act on its behalf for specified regulatory tasks. Registration in EUDAMED is required under Article 11 of the MDR (2017/745) and Article 11 of the IVDR — règlement (UE) 2017/746.
Frequently asked questions
What is an authorised representative?
An authorised representative is an EEA-based entity appointed by a non-EEA manufacturer to act on its behalf for specified regulatory tasks under Article 11 of the MDR (2017/745).
When is an authorised representative required?
A manufacturer established outside the EEA must designate a single authorised representative before placing a device on the EU market.
Are authorised representatives listed in EUDAMED?
Yes. Authorised representatives register in EUDAMED and are linked to the manufacturers they represent.