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.
Registration under these new regulations via the European database on medical devices (EUDAMED) is intended to centralise device information and help improve coordination of information on medical devices on the European market. EUDAMED will contain different modules on Economic Operators, Device and IVD registration, Unique Device Identification (UDI), Notified Bodies, Vigilance, Market Surveillance, Clinical Investigations and Performance Studies.
In October 2019, the EU Commission announced that it will only be possible to make EUDAMED operational once the entire system, and its associated modules, have achieved full functionality and have been subject to an independent audit. As such, the EU Commission announced a delay to full functionality of EUDAMED until 2022 at the earliest. Until further detail on the launch of the EUDAMED modules is provided by the EU Commission, the HPRA is asking that economic operators established in Ireland that wish to place MDR and IVDR compliant devices on the EU market register their organisation with us and their associated devices.
Who needs to register?
From May 2021, in accordance with the MDR (as amended), if you are a manufacturer* (including a manufacturer of custom made devices or system and procedure packs), or an authorised representative** located in Ireland, in the absence of EUDAMED, you should register your organisation and all device classes with the HPRA.
If you are a health care institution involved in the manufacturer of medical devices, you may fall under the definition of a manufacturer* and may be required to register.
If you are involved in the reprocessing of medical devices, you may fall under the definition of a manufacturer* and may be required to register.
(*Definition of a manufacturer: means a natural or legal person who manufactures or fully refurbishes a device or has a device designed, manufactured or fully refurbished, and markets that device under its name or trade name.
**Definition of an authorised representative: means any natural or legal person established within the Union who has received and accepted a written mandate from a manufacturer located outside the Union, to act on the manufacturer’s behalf in relation to specific tasks with regard to the latter’s obligations…)
Please contact the Medical Devices Department at email@example.com if you are in doubt about your registration obligations under the MDR.
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.
How do I register under MDR and IVDR?
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):
On registering your organisation with the HPRA, you should submit the HPRA device registration spreadsheet which you must complete if you wish to register devices. 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.
How do I register under Directive 93/42/EEC on medical devices and Directive 98/79/EC on in vitro diagnostic medical devices?
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 until May 2021.
If you have a registered place of business in the Republic of Ireland, you must register with the HPRA if you:
- manufacture class I or custom made medical devices and place them on the market under your own name, or trading name(s),
- manufacture custom made active implantable medical devices and place them on the market under your own name, or trading name(s),
- manufacture in-vitro diagnostic medical devices and place them on the market under your own name, or trading name(s),
- fully refurbish class I devices, or label one or more ready-made devices, with a view to placing these on the market under your own name,
- place medical devices bearing the CE marking on the market, in a system or a procedure pack,
- sterilise, for the purpose of placing on the market, systems or procedure packs or other CE marked medical devices designed by the manufacturers to be sterilised before use,
- are the designated European authorised representative for a manufacturer who does not have a registered place of business in the European community, and who places on the market devices within the above-listed categories.
For Organisation and Medical device registrations under the MDD and IVDD you can register with the HPRA online by submitting the relevant information through the Medical Devices Extranet.
Further information on the Extranet system is included in our guidance document for using the on-line device registration system.
How to register under the MDD and IVDD as a result of Brexit
On the 31 January 2020, the UK left the European Union, and became a ‘third county’. The UK have now officially entered a transition period in which negotiations are taking place for trade agreements with the EU. 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:
- 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.
You can register your organisation with the HPRA online by submitting the relevant information through the Medical Devices Extranet. Further information on the Extranet system is included in our guidance document for using the on-line device registration system.
How much does it cost?
An initial administration fee of €140 must be paid when registering with the HPRA. There is a yearly maintenance fee for registered organisations. Please refer to Section 8 of guide to relevant fee codes and payment instructions:
If you would like to know more information about registration, please contact the Medical Devices Department at firstname.lastname@example.org.