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.

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

Device details must be registered via the Eudamed device registration module.