Authorised representatives

What is an authorised representative?

An authorised representative is an EU entity who has received and accepted a written mandate from a manufacturer, located outside the EU, to act on the manufacturer's behalf in relation to specified tasks.

How do I register as an authorised representative?

Authorised representatives established in Ireland must register their organisation details on Eudamed, via the Eudamed actor registration module.

Authorised representatives should ensure that the associated non-EU manufacturer has linked their organisation to the relevant authorised representative on Eudamed.