Registration for Distributors of Medical Devices
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 distributor?
A distributor is an EU entity in the supply chain, other than the manufacturer or the importer, which makes a device available on the market, up until the point of putting into service. Distributors are sometimes referred to as ‘suppliers’ in the context of supplying devices to the market or the health services.
How do I register as a distributor?
Distributors established in Ireland must register their organisation details and device types nationally with the HPRA using our online registration form.
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: