Medical Device Registration Requirements

The new EU Medical Device Regulations entered into force in May 2017. The Regulation (EU) 2017/745 on medical devices (MDR) has a three-year transition period, plus an additional 12 months’ extension as a result of Covid-19, meaning it is fully applicable from 26 May 2021. Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) has a five-year transition period and is fully applicable from 26 May 2022. You can find full details of the New EU Medical Device Regulations here.

 

1. Who needs to register?

If you have a registered place of business in the Republic of Ireland, you must register with the HPRA if you fall under any of the below definitions:


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 ;

** 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;


Authorised representative -
An authorised representative means any natural or legal person established within the European Union 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 obligations under the Regulations/Directives.

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.

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.

Service Provider – means any service normally provided for at a distance, by electronic means and at the individual request of a recipient of services.  For example, entities that offer the provision of IVD test results on submission of a sample would be required to register as an Information Society Services provider.

System & Procedure Pack Manufacturer – the same obligations apply as manufacturer.  Under the MDR, entities placing system and procedure packs on the market are called ‘System and Procedure Pack Producers’.  They will need to register on EUDAMED and obtain an SRN.

Healthcare Institution - healthcare institution (eg a hospital or clinic) involved in the manufacture of medical devices may fall under the definition of a manufacturer and hence required to register.

 

It is important to note that from 26 May 2021, economic operators placing Class I medical devices on the market must ensure compliance with the 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. This excludes those Class I devices have been up-classified in accordance with the classification rules set out in Annex VIII of the MDR.

2. How do I register as a Manufacturer or Authorised Representative under MDR?

The HPRA has established an interim process for economic operators established in Ireland until EUDAMED is available. The process involves registering as an organisation and registering devices linked to your organisation number.

Registering Your Organisation

In order to register your organisation under Regulation (EU) 2017/745 on medical devices (MDR) or Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR):

  • Complete and submit the online registration for Economic Operators;
  • Read and sign the terms and conditions document and return the signed copy to the HPRA. (We will provide you with a copy of these terms and conditions once we receive your application);
  • Provide a copy of the mandate(s) for the manufacturer(s) that you represent (if registering as Authorised Representative);
  • Confirm if this registration is a result of the UK Exit from the European Union.

Please submit the above information to deviceregister@hpra.ie.

Please ensure that you only choose activities which relate to your organisation as fees will be generated based on your selection.

On receipt of all completed documentation, the HPRA will provide you with an interim HPRA Organisation Registration number.

Device Registration

On registering your organisation with the HPRA, you should submit the HPRA device registration spreadsheet which we will provide you with. Please ensure to quote your interim HPRA Organisation Registration number.

We are currently developing a new registration platform and once our new system is available, we will transfer your organisation and device details to the new system.  We will request that you examine and verify the content of your account on our new system, once live. This verification will require you to confirm your agreement to our terms and conditions of use and your compliance with the requirements of the MDR/IVDR.

3. How do I register as a Manufacturer or Authorised Representative under MDD & IVDD?

Directive 93/42/EC on medical devices (MDD) and Directive 98/79/EC on in vitro diagnostic medical devices (IVDD) will be repealed once the MDR and IVDR are fully applicable.  In the meantime, national registration requirements for devices placed on the market in accordance with the MDD and IVDD will apply.

Also, for any MDD and IVDD devices that are placed on the market after the date of application of the regulations (May 2021 (MDR) and May 2022 (IVDR)), in the context of Article 120, Transitional Provisions, these legacy products, if not already registered with the HPRA can be registered.

Registering Your Organisation

In order to register your organisation under Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices:

  • Complete and submit the online registration for the Medical Devices Extranet;
  • You will be prompted to print 2 terms & conditions (T&Cs). Please ensure that you have printed both T&Cs and pressed submit application as your application will not be completed if you do not press submit;
  • Sign the T&Cs and send 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 manufacturer that you represent (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.

Please ensure that you only choose activities which relate to your organisation as fees will be generated based on your selection.

Further information on the Extranet system is included in our Guide for Online Registration System for Medical Devices.

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

  • Complete and submit the online registration for Economic Operators.
  • Please ensure that you only select the relevant regulatory framework.
  • Read and sign the terms and conditions for MDR/ IVDR applications (these will be provided once we receive your application).
  • Provide a list of the device categories that relate to your business (we will provide you with a form once we receive your application).

 

Upon receipt of the completed online submission, you will receive an interim HPRA organisation registration number.

5. Additional requirements for registrations resulting from Brexit.

On the 31 January 2020, the UK left the European Union, and became a ‘third county’. All Manufacturers that are established in the UK will need to have an EU 27 Authorised Representative.

All organisations establishing in Ireland as a result of Brexit may register using our online system as a Legal Manufacturer or Authorised Representative provided that they have met the following conditions:

  • An entity has established in Ireland;
  • A written mandate is in place between the manufacturer of the outgoing UK based Legal Manufacturer/ Authorised Representative and the new incoming Irish based Legal Manufacturer/Authorised Representative;
  • The mandate should include the following: â—¦Date of termination of the mandate of the outgoing Legal Manufacturer/ Authorised Representative (if changing Authorised Representative),
  • Date of the beginning of the mandate of the incoming Legal Manufacturer/ Authorised representative (if applicable)
  • Roles and responsibilities of the parties called out in the mandate during transfer,
  • Details of the establishment of the incoming Legal Manufacturer/ Authorised Representative in Ireland,
  • Plan for transition and date for completion of labelling/ packaging/ IFU (and promotional material), updates to identify the incoming Legal Manufacturer/ Authorised Representative,
  • Details of how many complaints/ reports/ incidents will be managed during the transfer and how the system’s effectiveness will be monitored by the Legal Manufacturer/ Authorised Representative.

  

Please refer to the above sections:

  • How do I register as a manufacturer or Authorised Representative under MDR & IVDR
  • How do I register as a manufacturer or Authorised Representative under MDD & IVDD

6. How much does it cost?

An initial administration fee of €140 must be paid when registering with the HPRA under the medical device directives. There is a yearly maintenance fee for registered organisations. 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.