Registration 

Updated: 26 May 2021

Medical Device Registration Requirements

From 26 May 2021, economic operators placing class I medical devices on the market must be in compliance with Regulation (EU) 2017/745 on medical devices (MDR).  This means that from 26 May 2021, any class I medical devices, CE marked in accordance with Directive 93/42/EEC, can no longer be placed on the market.  Exceptions include those 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. 

Any registrations made to the HPRA under the Directive 93/42/EC on medical devices (MDD) and Directive 98/79/EEC on in vitro diagnostic medical devices (IVDD) do not qualify as registration obligations 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 the MDR/IVDR registration section. 

Information on the registration of economic operators and devices in accordance with the obligations set out in the MDR is outlined on this page.  Information on economic operators and IVDs compliant with Directive 98/79/EEC on in-vitro diagnostics (until May 2022) and with Regulation 2017/746 on in-vitro diagnostics is also included here. 

Please ensure you register under the relevant legislative framework (MDR, IVDR, IVDD) 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.  Depending on your role you may need to register at European level via Eudamed as an economic operator in accordance with the definition of manufacturer, authorised representative, importer and system and procedure pack producer.  Custom-made manufacturers, distributors, health institutions and manufacturing facilities are required to register nationally with the HPRA, if you are established in Ireland.

1. Who needs to register?

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 medical 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 medical 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 medical devices already on the market to their intended purpose for an individual patient, or

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.

A manufacturer will also be required to register on Eudamed. 

 

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 medical 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 medical devices, means a place where an entity, which does not place medical devices on the market under its own name or under its own trademark—

(a) manufactures a medical device, or

(b) manufactures one or more critical components of a medical device to a set of specifications, or

(c) carries out packaging activities in relation to a medical device, or carries out labelling activities in relation to a medical device.

A manufacturing facility is required to register on the national HPRA register.

 

Custom Made Manufacturer

An organisation that makes medical devices which are ‘custom-made devices’ 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 custom made device manufacturer is required to register via Eudamed if they manufacturer 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. How do I register under the MDR and IVDR?

Manufacturers, authorised representatives and system and procedure pack producers are requested to voluntarily register their details on Eudamed to meet the obligations set out in the MDR from 26th May 2021 and the IVDR from 26th May 2022. When Eudamed is fully functional, this will become a mandatory obligation. 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

The HPRA recognises the voluntary registration module of Eudamed 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 guidance 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 validation is complete, a single registration number (SRN) will be issued by Eudamed.
• The HPRA will create or update your registration on the HPRA national database.  

Please note that authorised representatives and non-EU manufacturers registering on Eudamed must ensure that their registrations are linked.  Specific guidance is given in the Eudamed guidance https://ec.europa.eu/health/md_eudamed/actors_registration_en,  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.

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 and implantable custom-made devices, one registration is sufficient to cover the role of the manufacturer and a manufacturer of class III and implantable custom made devices.

 
Registering an Economic Operator with the HPRA

While the HPRA recognises registrations on EUDAMED, there are some additional requirements at national level for cases where the economic operator is a:
• Custom-made manufacturer of class I, IIa, IIb custom-made devices.  
• Health institution e.g. hospital or clinic in Ireland involved in the manufacture of medical devices

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.

 

Device Registration

Before registering devices with the HPRA, it is preferable that your economic operator has been assigned an SRN or a HPRA registration number. 

As the voluntary registration module for devices on Eudamed is not yet available, the HPRA request that you register any MDR / IVDR compliant class I, system and procedure packs, custom-made devices and in-vitro diagnostic devices by submitting the device details to the HPRA using the relevant spreadsheet available for the link below:

MDR Spreadsheet
IVDR Spreadsheet


Organisations wishing to voluntarily register ‘legacy devices’ or MDR compliant devices that have been certified by a notified body can do so using the following: 

MDR Legacy Spreadsheet

The completed spreadsheet must be submitted to deviceregister@hpra.ie. The cover email must clearly identify the economic operator SRN or a HPRA registration number.   
Once the device module of Eudamed is available, the HPRA encourage manufacturer to register their devices on the 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. The current anticipated timeline for this module to go live is September 2021.

 

3. How do I register under the IVDD?

Registering an economic operator on the national database

In order to register the economic operator under IVDD, the HPRA request economic operators to:

• Complete the online registration form on the HPRA Medical Device Extranet
• Print two terms & conditions (T&Cs). Please ensure that you have printed both T&Cs and press the Submit button, as your application will not be completed until you press the Submit button.
• Sign the T&Cs and e-mail to deviceregister@hpra.ie (electronic submissions only).
• Pay the registration fee (code 431 - €140 per entity) and provide the HPRA with proof of payment.  Please click here for payment information.
• Provide a letter of designation for the non-EU manufacturer that you represent (required for authorised representatives only).
• Confirm if registration is a result of the UK exit from the European Union.

Please submit the above information to deviceregister@hpra.ie

 

Device Registration 

The HPRA requests that you register any IVDD compliant in-vitro diagnostic devices with the HPRA by submitting the device details via the HPRA Medical Device Extranet
If you need to submit a large number of devices, there is also an option of using a bulk upload spreadsheet.

IVDD Spreadsheet

The completed spreadsheet must be submitted to deviceregister@hpra.ie. The cover email must clearly identify the economic operator SRN or a HPRA registration number.   
Further information on the HPRA Medical Device Extranet is available in the Guide for Online Registration System for Medical Devices.

4. How do I register as an Importer or Distributor?

Importers

The HPRA recommend 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 recommend that you 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 Custom-Made Medical Device Manufacturers

Manufacturers of class I, class IIa and class IIb custom-made medical devices must register with the HPRA as a custom made device manufacturer.  Details on registering as an economic operator and device registration with the HPRA under the MDR/IVDR can be found above in Section 2.

Manufacturers of class III custom-made and implantable custom-made devices can register as an economic operator on Eudamed, as a manufacturer.  The HPRA will recognise the voluntary Eudamed system as a tool for complying with the national registration system in the absence of a fully functional Eudamed. If choosing to register nationally, class III custom-made and implantable custom-made device manufacturers will be required to register again on Eudamed once it is fully functional.  Details on how to complete Eudamed registration and national economic operator/device registration can be found above in Section 2. 

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 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.  
- 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.

Non-EU 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 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.  

Please note that we are currently experiencing a significant increase in the volume of applications as a result of the date of application for the MDR regulations, which may increase validation times.

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:

 

• Guide to Fees for Human Products

• Fee Application Form Human Products

• Payment of Fees Instructions

 

Annual fees for 2021

Code

9. MEDICAL DEVICES

        Fee

 

 

 

9.1 Certificates of Free Sale and Letters confirming the location of the manufacturing site in Ireland

 

 

 

411

Medical Device Certificates or Letters confirming the location of a manufacturing site in Ireland (four certificates per request)

255

 

-

413

Additional certificates/letters (available at the time of the initial request)

25

 

-

 

 

 

 

 

 

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

 

-

 

 

 

 

 

If you would like to know more information about registration, please contact the Medical Devices Department at devices@hpra.ie.

9. New HPRA Medical Device Portal 

The HPRA are currently developing a new medical device portal for registrations.  Once available, all economic operator and device registration will be transferred to the new portal.

Each economic operator will be notified when the new portal goes live.  The HPRA will request that economic operators examine and verify the content of their account, once live.  This verification will require all users to agree to new terms and conditions of use.

At a future date, the HPRA hope to establish a machine to machine link to Eudamed, where the HPRA will download economic operator and device data relating to Irish based economic operators and their associated non-EU manufacturers to HPRA medical device portal.  This will ensure that the records are identical and will avoid the need for dual data entry by economic operators. 

Further information on the new HPRA medical device portal will be provided on this webpage, once available. 

 

10. 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. 

Please note that the HPRA are currently experiencing a significant increase in the volume of queries and applications as a result of the approaching date of application for the MDR.

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