Registration requirements

This page is for device industry.

It provides information on how to register your organisation and device details.

For more information on key topics relating to registration, please click on the drop-down menu below.

1. Who needs to register?

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

2. How do I register under the MDR or IVDR?

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.

Organisations may also register ‘MDR legacy devices’ using the device registration module. 

3. HPRA national registration requirements

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.

4. Validation of economic operators on Eudamed

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.

5. How much does it cost to register? 

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:


Annual Fees for 2021






9.2 Registration of Devices



Online Registration



Administration fee






9.3 Annual Fee for manufacturer (as defined by an EU legislation) and/or a manufacturing facility(manufacturing site) located in Ireland



Manufacturers with more than 150 employees



Manufacturers with 100- 150 employees



Manufacturers with 50- 99 employees



Manufacturers with 16- 49 employees



Manufacturers with 5- 15 employees



Manufacturers with fewer than 5 employees or with annual turnover of less than €500,000






9.4 Annual Fee for Authorised Representatives



Type I AR - representing a non EU manufacturer that manufactures low risk devices (fee per manufacturer)



Type II AR - representing a non EU manufacturer that manufactures high risk devices or a mix of high & low risk devices (fee per manufacturer)



Cap applicable to Type I AR



Cap applicable to Type II AR






9.5 Annual Fee for Distributors and Importers



Large Distributor/Importer ( turnover greater than €15 million)



Medium Distributor/Importer (turnover €3 - €15 million)



Small Distributor/Importer (turnover under €3 million)



Distributor/Importer turnover less than €500,000



Additional supplement - Entities acting as both a Distributor and Importer



Additional supplement - Entities acting as both a Distributor and Importer - turnover less than €500,000


6. Registration queries

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

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.