The Medical Devices Regulation (MDR) became fully applicable across the EU on 26 May 2021. It represents a much-anticipated strengthening of the existing regulatory framework for medical devices in Europe and imposes significant new obligations for economic operators across the medical device supply chain.
In this article, we look at the current status of registration requirements under the MDR.
Article 33 of the MDR mandated the creation of a European database on medical devices (EUDAMED). This database aims to streamline and facilitate information flow between economic operators, notified bodies, clinical trial sponsors and member states and inform the public about devices on the market. The portal is structured around six interconnected modules:
- Actors registration
- UDI/Devices registration
- Notified Bodies and Certificates
- Clinical Investigations and performance studies
- Vigilance and post-market surveillance
- Market Surveillance
Currently, the first of these six modules, Actors registration, is fully functional. According to the Commission, the second and third modules will become available in September 2021.
EUDAMED – Actor Registration
- Under the Actor registration module, economic operators across the supply chain (EU and non-EU manufacturers, authorised representatives, system/procedure pack producers and importers) may submit registration requests through the EUDAMED portal.
- These requests then require validation by their national competent authority – the Health Products Regulatory Authority (HPRA) in Ireland. Following assessment and approval of the request by the national competent authority, EUDAMED provides a Single Registration Number (SRN) of the economic operator to the national competent authority and transfers it to the requesting economic operator.
The SRN guarantees an EU-wide unique identification for economic operators.
- An economic operator is required to obtain a separate SRN for each Actor role it performs.
- Manufacturers established outside the EU 27 countries, Iceland, Liechtenstein, Norway or Northern Ireland, will be able to register only if their authorised representative is established within the EU 27, Iceland, Lichtenstein, Norway or Northern Ireland, and its authorised representative verifies the registration request before passing it to the national competent authority for assessment.
The Commission has published helpful guidance documents to assist economic operators in navigating the new systems. These are available here.
- Since the MDR entered into force, the HPRA has published a suite of guidance on the registration requirements for medical devices. In addition to requirements under EUDAMED, certain economic operators established in Ireland are required to register domestically with the HPRA. Distributors and manufacturing facilities, who avoid registration requirements under EUDAMED, must register with the HPRA. Similarly, health institutions in Ireland, such as hospitals or clinics involved in the manufacture of medical devices, are required to register with the HPRA.
- Where an operator manufactures custom-made devices (under Class I, IIa and IIb of the MDR classification), it must register with HPRA as a custom-made device manufacturer. Conversely, if an operator manufactures custom-made class III or implantable devices, it must register via EUDAMED.
The HPRA registration form is available here. Following receipt of all completed documentation, the HPRA will provide the relevant economic operator with a HPRA registration number.
- 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, available here and here.
- 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 stated that it is developing a new medical device portal for registrations. Once available, all economic operator and device registration data will be transferred to the new portal. Ultimately, the HPRA aims to establish a machine to machine link between this portal and EUDAMED. This will ensure that the records are identical and will avoid the need for dual data entry. No date has been published for the establishment of this portal.
Despite the Actors registration module being up and running on EUDAMED, economic operators should note that the requirements of the MDR which relate to EUDAMED will not apply until six months after the Commission has given notice under Article 34(3) that the database is fully functional.
As such, while the technical infrastructure is available to enable Actors to register on EUDAMED, registration remains non-compulsory. The Commission most recently estimated that the deployment of a fully functional EUDAMED will take place in the first half of 2023, so the present situation looks set to persist. In the meantime, the HPRA has stated that it “recognises the voluntary registration module of EUDAMED in the absence of a fully functional EUDAMED.”
On the other hand, custom-made manufacturers, distributors, health institutions and Irish manufacturing facilities required to register with the HPRA as opposed to EUDAMED, should take immediate action regarding the HPRA registration requirements.
At present, the landscape for registering economic operators and medical devices under the MDR is in a state of flux. Despite a fully functioning EUDAMED being a “high priority” for the Commission, there appears to be quite a road ahead to achieve this aim.
We will continue to monitor further updates from the Commission and the HPRA and keep you updated. If you require additional information on any aspect of the MDR or IVDR, please contact Charleen O’Keeffe.
Contributed by Darragh Larkin