Registration requirements

Economic operators must comply with the registration requirements of the Medical Devices Regulation (MDR) and the In Vitro Diagnostics Medical Devices Regulation (IVDR).

S.I. 691/2021 details the national provisions underlying these requirements.

The following entities must register as economic operators; 

• Manufacturers
• Custom made device manufacturers
• Manufacturing facilities
• Authorised representatives
• System and procedure pack producers
• Importers
• Distributors  
• Health institutions

We request the following entities to register their economic operator and device details on Eudamed:

• Manufacturers (including manufacturers of Class III custom made medical devices)
• Importers,
• Authorised representatives,
• Non-EU manufacturers whose authorised representative is based in Ireland,
• System and procedure pack producers.

How do I register as an economic operator on Eudamed?

For more information on how to use the Eudamed actor registration module, please go to the Commission’s designated webpage.

When completing your registration on Eudamed, please follow the instructions provided in the Eudamed user guide.

If you meet the definition of more than one type of economic operator, you must complete multiple Eudamed registrations.

We recognise the voluntary registration module of Eudamed in the absence of a fully functional Eudamed. Once Eudamed is fully functional, this will become the mandatory registration system.

How do I register my devices on Eudamed?

Economic operators must register the following devices using the Eudamed device registration module;

• MDR compliant class I, IIa, IIb, III and class III implantable custom-made devices, system and procedure packs and,
• IVDR compliant devices.

For more information on how to use the Eudamed device registration module, please go Commission’s designated webpage.

Who needs to register with the HPRA nationally?

We require the following Irish-based economic operators to register with us;

• Custom made device manufacturers of class I, IIa, IIb custom-made devices,
• Health institutions i.e., hospitals or clinics involved in the manufacture of devices,
• Manufacturing facilities, and
• Distributors.

How do I register as an economic operator with the HPRA?

To register with us, you can complete and submit our online registration form.

On receipt of all completed documentation, we will provide you with a HPRA registration number.

How do I register my devices with the HPRA?

Upon receipt of a completed online registration form, we will provide the relevant documents to register your devices.

We validate Eudamed registration applications for Irish-based economic operators and their non-EU manufacturers. We will return incomplete applications to you for completion. Once validated, you will receive a single registration number (SRN) from Eudamed.

System and procedure pack producers

We validate Eudamed registrations for system and procedure pack producers (SPPP) where:

• The SPPP is based in Ireland,

• The SPPP is also a non-EU manufacturer with an authorised representative in Ireland. 

Non-EU SPPPs must include the SRN for the non EU manufacturer and the SRN of the authorised representative in Ireland. This information must be in the comments section of the Eudamed registration application.

Validation timelines

We review registration applications received via Eudamed, new and re-submitted, within two working days in order of receipt.
We validate complete applications within five working days.

An initial administration fee of €140 must be paid when registering directly with the HPRA.

There is a yearly maintenance fee for all registered economic operators. Invoices are sent to economic operators in quarter 2 of each year.

Please refer to section 8 of guide to relevant fee codes and payment instructions:

• Guide to Fees for Human Products
• Fee Application Form Human Products
• Payment of Fees Instructions

If you have any queries relating to the registration, please first refer to the information on this page. If this page does not address your query, please email deviceregister@hpra.ie

Queries are reviewed in order of receipt. Please do not submit duplicate queries. 

We will endeavour to provide a response to your request within 10 working days.