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.
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 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.
Frequently asked registration questions
How does the HPRA process registration applications?
Eudamed applications
We validate Eudamed registration applications for Irish-based:
- Manufacturers
- Authorised representatives and their non-EU manufacturers
- Importers
- System and procedure pack producers
Once validated, you will receive a single registration number (SRN) from Eudamed. Registrations validated on Eudamed will also be registered nationally.
National registration applications
We validate registration applications for Irish-based:
- Distributors
- Manufacturing facilities
Once validated, you will receive a HPRA registration number.
Eudamed and national registration applications will be processed within 10 working days.
How much does it cost to register?
There is an annual maintenance fee for all registered economic operators. This is based on the registration information provided to us both directly and via EUDAMED so it is important to keep information up to date. Invoices are sent to economic operators in quarter 2 of each year.
An additional administration fee must be paid by any entities that register directly with the HPRA (i.e. not via EUDAMED). This fee must be received before registration is confirmed.
Please refer to section 9 of our fee application form for human products below to see relevant fee codes and payment instructions. Additional resources relating to fees are also provided below.
How do I contact the HPRA?
What is the legal basis for registering with the HPRA?
Registration obligations for economic operators are outlined in Chapter III of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Medical Devices Regulation (IVDR).
National requirements relating to the registration of organisations and health institutions established in Ireland are provided for in: