MDR current Registration Requirements (EUDAMED) for the EU and additional registration requirements for the Republic of Ireland.
On May 26, 2021, the Medical Devices Regulation (MDR) became completely applicable throughout the EU. It is a much-anticipated strengthening of Europe's existing medical device regulatory framework, and it imposes important new requirements on economic operators throughout the medical device supply chain.
What are the MDR's current registration requirements?
Article 33 of the MDR mandated the construction of a European medical device database (EUDAMED). This database intends to improve information flow between economic operators, notified organizations, clinical trial sponsors, and member states, as well as inform the general public about products on the market.
Six interrelated modules make up the portal's structure:
- Registration of actors (currently operational);
- Registration of UDIs and Devices (available September 2021);
- Certificates and Notified Bodies (available September 2021);
- Clinical trials and performance evaluations;
- Post-market surveillance and vigilance;
- Market Observation.
Economic operators from across the supply chain (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers, and importers) can use the EUDAMED platform to submit registration requests.
These requests must then be validated by their national responsible authority. Following the national competent authority's assessment and approval of the request, EUDAMED issues a Single Registration Number (SRN) to the national competent authority and transfers it to the requesting economic operator.
For economic operators, the SRN ensures a unique identification across the EU. For each Actor role that an economic operator undertakes, it must obtain a different SRN.
Manufacturers based outside of the EU 27, Iceland, Liechtenstein, Norway, or Northern Ireland will be able to register only if their authorised representative is based within the EU 27, Iceland, Liechtenstein, Norway, or Northern Ireland, and the authorised representative verifies the registration request before submitting it to the national competent authority for assessment.
MDR Current Registration Requirements & Additional HPRA (Ireland) Registration Requirements
The Health Products Regulatory Authority (HPRA) in Ireland has published registration requirements additionally to EUDAMED.
1. The HPRA has produced a suite of guidelines on the registration requirements for medical devices since the MDR went into effect. In addition to the EUDAMED requirements, certain economic operators based in Ireland are required to register with the HPRA on a national level. Distributors and production facilities who want to evade EUDAMED's registration requirements must register with the HPRA instead. Similarly, health institutions in Ireland that manufacture medical equipment, such as hospitals or clinics, are required to register with the HPRA.
2. An operator must register with HPRA as a custom-made device manufacturer if it makes custom-made devices (classes I, IIa, and IIb of the MDR classification). In contrast, if a company makes custom-made class III or implantable medical devices, it must register with EUDAMED.
– Regarding the registration of devices, the HPRA has requested that, in the absence of the EUDAMED module for registration, details for any MDR / IVDR compliant class I devices, system and procedure packs, custom-made devices and in-vitro diagnostic devices should be submitted to the HPRA using the relevant MDR Spreadsheet or IVDR Spreadsheet
– There is also an MDR Legacy Spreadsheet that may be used to voluntarily register ‘legacy devices’ or MDR compliant devices that have been certified by a notified body. Legacy devices are medical devices covered by a valid certificate under the old Directives, which can continue to be placed on the market until 27 May 2024 and made available until 27 May 2025.
– The HPRA has advised that economic operators should ideally have an SRN issued by EUDAMED or a HPRA registration number before registering devices with it.
Separately, the HPRA has announced that it is working on a new medical device registration platform. All economic operator and device registration data will be transferred to the new portal once it is available. The HPRA's ultimate goal is to create a machine-to-machine interface between this portal and EUDAMED. This guarantees that the records are identical and eliminates the need for duplicate data entering. The launch date for this portal has yet to be announced.
Despite the fact that the Actors registration module on EUDAMED is operational, economic operators should be aware that the MDR's requirements for EUDAMED will not take effect until six months after the Commission has given notice under Article 34(3) that the database is fully operational.
As a result, while the technological infrastructure to enable Actors to register on EUDAMED is in place, registration is voluntary.
The deployment of a fully functional EUDAMED is expected to take place in the first half of 2023, according to the most recent estimates from the Commission, therefore the current scenario appears to be poised to continue. In the interim, the HPRA has indicated that "in the absence of a fully working EUDAMED," it "recognizes the voluntary registration module of EUDAMED."
Custom-made manufacturers, distributors, health institutions, and Irish manufacturing facilities, on the other hand, should take immediate action to comply with the HPRA registration requirements rather than EUDAMED.
Conclusion to MDR Current Registration Requirements
The environment for registering economic operators and medicinal devices under the MDR is currently in flux.
Despite the Commission's declaration that a fully functional EUDAMED is a "high priority," it appears that there is still a long way to go to achieve this goal.
To help economic operators navigate the new systems, the Commission has prepared helpful guide sheets. These can be found here.
MDR Current Registration Requirements (EUDAMED) for the EU and additional registration requirements for the Republic of Ireland.