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Registration requirements

This page is for device industry established in Ireland and for health services using medical devices and in vitro diagnostic medical devices (IVDs). 

It also applies to non-EU manufacturers with an authorised representative established in Ireland.

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

Registration obligations must be fulfilled before products are placed on the market or used.

How do I register? 

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.  

Definitions and instructions are provided below to clarify the various roles. 

Manufacturers

Learn more about registration requirements for manufacturers established in Ireland.

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Authorised representatives

Learn more about registration requirements for authorised reps established in Ireland.

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Non-EU manufacturers

Learn more about registration requirements for non-EU manufacturers with an authorised rep established in Ireland.

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Importers

Learn more about registration requirements for importers established in Ireland.

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System and procedure pack producers

Learn more about registration requirements for system and procedure pack producers established in Ireland.

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Distributors

Learn more about registration requirements for distributors established in Ireland.

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Manufacturing facilities

Learn more about registration requirements for manufacturing facilities established in Ireland.

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Manufacturers of custom made devices

Learn more about registration requirements for manufacturers of custom made devices established in Ireland.

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Health institutions

Learn more about notification requirements for health institutions established in Ireland.

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Frequently asked questions

How does the HPRA process registration applications?

We validate Eudamed registration applications for economic operators established in Ireland and their non-EU manufacturers. Once validated, you will receive a single registration number (SRN) from Eudamed.  

Any registrations validated on Eudamed will also be registered nationally. 

Complete registration applications, national and Eudamed, 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?
If this page does not address your query, or you wish to request a letter confirming your organisation or device registrations, please contact us via our online contact form.
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: