Manufacturers established in Ireland 

This information applies to manufacturers of medical devices and IVDs established in Ireland. 

Manufacturers based in other EU member states who have  registered via Eudamed do not need to register with the HPRA to place their products on the Irish market.

What is a manufacturer?

A manufacturer is any entity who manufactures or fully refurbishes a device or has a device designed, manufactured, or fully refurbished, and markets that device under its name or trademark.

How do I register as a manufacturer of medical devices/IVDs?

Manufacturers of medical devices and/or IVDs must register their organisation and device details on Eudamed.

To register organisation and device 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. 

For more information on how to register device details please see the Eudamed device registration module.