System and procedure pack producers
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 system and procedure pack producer?
A system or procedure pack producer is a natural or legal person who places systems or procedure packs on the EU market.
‘System’ means a combination of products, either packaged together or not, which are intended to be interconnected or combined to achieve a specific medical purpose. Examples of systems include diagnostic equipment such as X ray systems or CT scan systems.
‘Procedure pack’ means a combination of products packaged together and placed on the market with the purpose of being used for a specific medical purpose. Examples of procedure packs include first aid kits, orthodontic procedure packs and wound exchange kits.
How do I register as a system and procedure pack producer?
System and procedure pack producers established in Ireland 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: