Non-EU manufacturers with an authorised representative established in Ireland

This information applies to non-EU manufacturers of medical devices and IVDs with authorised representatives established in Ireland. 

What is a non-EU manufacturer? 

A non-EU 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. Non-EU manufacturers are located outside of the EU member states. Non-EU countries are also known as third countries. In this context, a third country means any country located outside of the EU.

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

Non-EU 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

Non-EU manufacturers must link their organisation to an authorised representative via Eudamed. This step can only be done once the authorised representative has obtained a single registration number (SRN) from EUDAMED.