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.

Before you register, you must identify and confirm your role within the device supply chain. 

Your role determines the requirements that apply to you. 

If you meet the definition of more than one role, you must register for each role separately. 

How do I register as an authorised representative?

Authorised representatives established in Ireland must register their organisation details on Eudamed.

To register organisation details, you can login or create an account on the Eudamed landing page.

For more information on how to register organisation details, please see 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.