Importers

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. 

Organisation details must be registered via the Eudamed actor registration module. 

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