Importers

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.

What is an importer?

An importer is an EU entity that places a device from a third country on the EU market.

A third country refers to any country not in the EU. 

How do I register as an importer?

Importers 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. 

Following validation on EUDAMED, the HPRA will contact registered importers to provide further information on the imported devices.