From 26 May 2021, economic operators placing class I devices on the market must be in compliance with Regulation (EU) 2017/745 on medical devices (MDR). Exceptions to this include MDD class I devices that fall within the scope of Article 120 of the MDR, such as class I devices with a valid notified body certificate under the Directives or devices up-classified under the MDR.
From 26 May 2022, the in-vitro diagnostics medical devices Regulation (EU) 2017/746 (IVDR) is fully applicable and economic operators placing IVDR compliant devices on the market will have to fulfil the registration requirements set out on this page.
Any registrations with the HPRA under Directive 93/42/EC on medical devices (MDD) and Directive 98/79/EEC on in vitro diagnostic medical devices (IVDD) do not qualify as registrations under the Regulations (MDR/ IVDR). If you are placing devices on the market under the Regulations, you must follow the registration steps to register under Section 2 below on MDR/IVDR registration.
This page sets out the registration requirements for economic operators and devices in accordance with the:
It is important to select the appropriate legislative framework (MDR, IVDR) that applies to your devices and that you define your role as an economic operator or actor in the device supply chain in accordance with the various definitions set out in the legislation.
Registration for economic operators that qualify as manufacturers, authorised representatives, importers and system and procedure pack producers, are required to register centrally on Eudamed. Other actors established in Ireland, such as distributors, health institutions and manufacturing facilities should register nationally with the HPRA.
Manufacturers of custom made devices (Class III implantable devices) are required to register on Eudamed. Manufacturers of all other classes of custom made devices must register with the HPRA as outlined below.
1. Who Needs To Register?
The requirement to register as an economic operator applies to manufacturers, authorised representatives, system and procedure pack producers, importers, distributors, health institutions and manufacturing facilities. The role of each economic operator is defined below:
Manufacturer
(i) a person who is responsible for the design, manufacture, packaging and labelling of a device before it is placed on the market under his or her own name, regardless of whether these operations are carried out by that person himself or herself or on his or her behalf by a third party; or
(ii) a person who assembles, packages, processes, fully refurbishes or labels one or more ready-made products or assigns to them their intended purpose as a device with a view to their being placed on the market under his or her own name, but not including a person who assembles or adapts devices already on the market to their intended purpose for an individual patient.
And/or has the meaning assigned to it by-
(i) Article 2(30) of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 or
(ii) Article 2(23) of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017.
Most manufacturers will be required to register on Eudamed. However manufacturers who only manufacturer class I, class IIa and class IIb custom-made devices do not have to register via Eudamed instead they must register directly on the national HPRA register.
Authorised representative
An authorised representative means any natural or legal person established within the EU who has received and accepted a written mandate from a manufacturer located outside the EU, to act on the manufacturer’s behalf in relation to specified tasks with regard to the latter’s obligations under the Regulations/Directives. An authorised representative will be required to register on Eudamed.
Importer
An importer is defined as any natural or legal person established in the EU that places a device from a third country on the EU market. An importer will be required to register on Eudamed.
System & Procedure Pack Producer
The same registration obligations apply as a manufacturer. Under the MDR, entities placing system and procedure packs on the market are called ‘system and procedure pack producers’. A system and procedure pack producer will be required to register on Eudamed.
Distributor
A distributor is defined as any natural or legal person in the supply chain, other than the manufacturer or the importer that makes a device available on the market, up until the point of putting it into service. A distributor is required to register on the national HPRA register.
Health Institution
Health institution (e.g. hospital or clinic) involved in the manufacture of devices may fall under the definition of a manufacturer. A health institution is required to submit information on the national HPRA register.
Manufacturing Facility
In the context of devices, means a place where an entity, which does not place devices on the market under its own name or under its own trademark—
(a) manufactures a device, or
(b) manufactures one or more critical components of a device to a set of specifications, or
(c) carries out packaging activities in relation to a device, or carries out labelling activities in relation to a device.
A manufacturing facility is required to register on the national HPRA register.
Custom Made Manufacturer
‘custom-made device’ means any device specifically made in accordance with a written prescription of any person authorised by national law. The device is intended for the sole use of a particular patient exclusively to meet their individual conditions and needs. A manufacturer of custom made devices is required to register via Eudamed if they manufacture custom made class III or implantable devices, and directly on the national HPRA register if they manufacturer class I, class IIa and class IIb custom made medical devices.
2. MDR/IVDR Registration Requirements - How to Register.
The HPRA recognises 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.
The HPRA is therefore requesting that MDR and IVDR manufacturers, authorised representatives and MDR system and procedure pack producers voluntarily register their details on Eudamed to meet the obligations set out in the Regulation.
Once the registration application on Eudamed has been validated by their competent authority, the economic operator will receive a single registration number (SRN), which is issued by Eudamed.
Registering an Economic Operator on Eudamed
Registering an economic operator under the MDR or IVDR is dependent on the role of the economic operator. If the economic operator is a:
- Manufacturer (includes manufacturers of class III and implantable custom-made devices.
- Authorised representative
- Non-EU manufacturer whose authorised representative is based in Ireland
- System and procedure pack producer
Depending on the activities/responsibilities of economic operators, multiple registrations on Eudamed will be required. For example, separate registrations are required for manufacturers, authorised representatives, system and procedure pack producers and importers.
For manufacturers of class III implantable custom-made devices, one registration is sufficient to cover the role of the manufacturer and a manufacturer of class III implantable custom made devices.
To complete a registration on Eudamed:
Please note that authorised representatives and non-EU manufacturers registering on Eudamed must ensure that their registrations are linked. Specific guidance is given in here and in the European Commissions Guide to Using Eudamed’s Actor Registration Module. A non-EU manufacturer will require the SRN for its authorised representative before registering on Eudamed. The non-EU manufacturer must provide documented evidence of their mandate with their authorised representative
Device Registration on Eudamed
MDR / IVDR compliant class I, IIa, IIb, III and class III implantable custom made devices, system and procedure packs and in-vitro diagnostic devices should be registered by using the voluntary registration module for devices on Eudamed:
https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en
Organisations wishing to voluntarily register ‘MDR legacy devices’ can do so by using the voluntary registration module for devices on Eudamed:
https://ec.europa.eu/health/md_eudamed/udi_devices_registration_en
The European Commission also have a User Guide to the UDI-DI/Devices Module.
3. HPRA National Registration Requirements
National Economic Operator Registration
National registration with the HPRA is required for the following economic operators:
- Manufacturers of class I, IIa, IIb custom-made devices;
- Health institutions e.g. hospital or clinic in Ireland involved in the manufacture of devices;
- Read and sign the terms and conditions document and return the signed copy to the HPRA. A copy of the terms and conditions will be provided by the HPRA on receipt of the application;
- On receipt of all completed documentation, the HPRA will provide you with a HPRA registration number.
National Device Registration
Before registering devices, it is preferable that your economic operator has been assigned an SRN or a HPRA registration number.
MDR compliant class I, IIa, IIb custom-made devices can be registered with the HPRA by submitting the device details to the HPRA using the spreadsheet available for the link below:
MDR Spreadsheet
4. How Do I Register As An Importer Or Distributor?
Importers
The HPRA request that importers register using the voluntary registration module of Eudamed. The HPRA will recognise the voluntary system as a tool for complying with the national registration system in the absence of a fully functional Eudamed.
To complete a registration on Eudamed:
- Log on to the EU Commission website https://webgate.ec.europa.eu/eudamed/landing-page#/ and create an account https://webgate.ec.europa.eu/cas/login.
- Follow the step-by-step guidance that is provided https://ec.europa.eu/health/md_eudamed/actors_registration_en and register the economic operator.
- Once all of the necessary information and appropriate supporting documentation has been provided, submit the registration.
- The registration application will be reviewed and validated by the HPRA, once all the appropriate information has been provided.
- Once completion of validation, a single registration number (SRN) will be issued by Eudamed.
- The HPRA will create or update your registration on the HPRA national database.
- The HPRA will also request a list of the device categories that relate to the business of the importer.
Distributors
The HPRA request that distributors register by following the steps
- Complete and submit the online form for economic operators.
- Select only the relevant regulatory framework.
- Read and sign the terms and conditions document and return the signed copy to the HPRA. A copy of the terms and conditions will be provided by the HPRA on receipt of the application.
- Provide a list of the device categories that relate to the business of the distributor. A form will be provided by the HPRA on receipt of the application.
- On receipt of all completed documentation, the HPRA will provide you with a HPRA registration number.
If you act as both an importer and a distributor, you will be required to register twice; once as an importer and once as a distributor following the two processes outlined above.
5. Registration For Manufacturers Of Custom-Made Medical Devices
Manufacturers of class I, class IIa and class IIb custom-made medical devices established in Ireland must register with the HPRA as a manufacturer.
The HPRA request these economic operators to:
- Complete and submit the online form for economic operators.
- Read and sign the terms and conditions document and return the signed copy to the HPRA. A copy of the terms and conditions will be provided by the HPRA on receipt of the application.
- On receipt of all completed documentation, the HPRA will provide you with a HPRA registration number.
MDR compliant class I, IIa, IIb custom-made devices can be registered with the HPRA by submitting the device details to the HPRA using the spreadsheet available for the link below:
MDR Spreadsheet
Manufacturers of class III implantable custom-made devices established in Ireland must register themselves as an economic operator and their custom – made devices on Eudamed. The HPRA recognise the voluntary Eudamed system as a tool for complying with the national registration system in the absence of a fully functional Eudamed.
Details on how to complete Eudamed registration can be found in Section 2 and national economic operator/device registration can be found above in Section 3.
6. Registration For Manufacturing Facilities
The HPRA recommends that you register by following these steps:
- Complete and submit the online form for economic operators.
- Select the relevant regulatory framework (e.g., MDR, MDD, IVDR, IVDD)
- A copy of the terms and conditions will be provided by the HPRA on receipt of the application.
- Read and sign the terms and conditions document and return the signed copy to the HPRA.
- On receipt of all completed documentation, the HPRA will provide you with a HPRA registration number.
7. Validation Of Economic Operators On Eudamed
All registration applications received on Eudamed for Irish based economic operators and their associated non-EU manufacturers must be validated by the HPRA. Incomplete registration applications will be returned to the economic operator for completion. Once validated, the economic operator will receive a single registration number (SRN) issued by Eudamed.
The HPRA require the following information for a successful application on Eudamed:
Economic operators located in Ireland
Actor Identification
- VAT number (IE prefix and number/letter).
- EORI number (IE prefix and number/letter). If no EORI number, please enter ‘no EORI’.
- CRO number in the National Trade Register field.
Actor address
- Full actor address, including the county and Eircode.
Actor Contact Details
- Contact name
- Email address
- Telephone number x 2
- Website. If no website, please enter ‘no website’.
- Regulatory Persons (if applicable to economic operator role)
- Full PRRC contact information, including the county and Eircode.
Registering Local Access Administrator
- Signed Declaration of Information Security document, which should include the following:
- name of legal entity on page 1.
- correct economic operator role on page 1.
- full postal address on page 1.
- contact information on page 2.
- digital or scanned signature on page 4.
Non-EU manufacturers
Actor Identification
- EORI number, if applicable. If no EORI number, please enter ‘no EORI’.
- National Trade Register number in the National Trade Register field, if applicable.
- Organisation identification document specific to non EU manufacturer's address. Examples include the following:
- Proof of registration with national trade register within the non EU manufacturer's jurisdiction or
- A notarised document confirming the company name, location and contact details for the company director/manager.
Authorised Representative
- Authorised representative information, including SRN.
- A mandate to include the following information:
- Mandate should be on letterhead paper of the non EU manufacturer.
- Name, address, contact details of the non EU manufacturer.
- Name, address, contact details of the authorised representative name.
- Legislative framework.
- Generic device group(s) the authorised representative is responsible for. Generic device group means a set of devices having the same or similar intended purposes or a commonality of technology allowing them to be classified in a generic manner not reflecting specific characteristics.
- Non EU manufacturer’s signature (Include printed contact name).
- Authorised representative’s signature (Include printed contact name).
Actor address
- Full actor address, including the postcode/zipcode.
Actor Contact Details
- Contact name
- Email address
- Telephone number x 2
- Website. If no website, please enter ‘no website’.
Regulatory Persons (if applicable to economic operator role)
- Full PRRC contact information, including the postcode/zipcode.
Registering Local Access Administrator
- Signed Declaration of Information Security document, which should include the following:
- name of legal entity on page 1.
- correct economic operator role on page 1.
- full postal address on page 1.
- contact information on page 2.
- digital or scanned signature on page 4.
Please note all uploaded documentation should be provided in English.
System and procedure pack producers
The HPRA will validate Eudamed registrations for system and procedure pack producers (SPPP) in the following scenario:
- The SPPP is located in Ireland
- The SPPP is also a non-EU manufacturer with an authorised representative designated in Ireland.
To assist with the validation process, the system and procedure pack producer that is located outside of the EU should include the SRN for the non EU manufacturer and the SRN of the authorised representative established in Ireland. This information should be included in the comments section of the Eudamed registration application.
Validation timelines
All registration applications received via Eudamed, new and re-submitted, will be reviewed by the HPRA within two working days. Applications are reviewed in order of receipt.
Registration applications will be validated within two working days on receipt of a complete application.
8. 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 | | MEDICAL DEVICES | Fee |
| | |
|
| | 9.2 Registration of Devices | |
| | Online Registration | |
| 431 | Administration fee | 140 |
| | | |
| | 9.3 Annual Fee for manufacturer (as defined by an EU legislation) and/or a manufacturing facility(manufacturing site) located in Ireland | |
| 458 | Manufacturers with more than 150 employees | 30,600 |
| 459 | Manufacturers with 100- 150 employees | 20,400 |
| 470 | Manufacturers with 50- 99 employees | 15,300 |
| 460 | Manufacturers with 16- 49 employees | 5,100 |
| 461 | Manufacturers with 5- 15 employees | 1,275 |
| 462 | Manufacturers with fewer than 5 employees or with annual turnover of less than €500,000 | 250 |
| | | |
| | 9.4 Annual Fee for Authorised Representatives | |
| 464 | Type I AR - representing a non EU manufacturer that manufactures low risk devices (fee per manufacturer) | 1,100 |
| 438 | Type II AR - representing a non EU manufacturer that manufactures high risk devices or a mix of high & low risk devices (fee per manufacturer) | 1,500 |
| 439 | Cap applicable to Type I AR | 5,500 |
| 440 | Cap applicable to Type II AR | 7,500 |
| | | |
| | 9.5 Annual Fee for Distributors and Importers | |
| 465 | Large Distributor/Importer ( turnover greater than €15 million) | 4,590 |
| 466 | Medium Distributor/Importer (turnover €3 - €15 million) | 2,550 |
| 467 | Small Distributor/Importer (turnover under €3 million) | 1,275 |
| 468 | Distributor/Importer turnover less than €500,000 | 250 |
| 479 | Additional supplement - Entities acting as both a Distributor and Importer | 1,000 |
| 480 | Additional supplement - Entities acting as both a Distributor and Importer - turnover less than €500,000 | 250 |
9. Registration Queries
If you have any queries relating to the registration of economic operators and devices, please first refer to the information provided on the registration webpages. If the information on the registration webpages does not address your query, please e-mail 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.