On 21 November 2024, the European Commission released a Q&A document on the application of Regulation (EU) 2024/1860, addressing the gradual roll-out of EUDAMED. Article 34 of the Medical Device Regulation (MDR), as revised by Regulation 2024/1860, allows for the gradual implementation of EUDAMED, by making individual modules of EUDAMED mandatory sooner.
With this document, the Commission clarifies important points addressing EUDAMED modules’ roll-out.
Transitional periods of EUDAMED mandatory use
Articles 123(3)(d) MDR and 113(3)(e) IVDR establish that EUDAMED use becomes mandatory six months after the European Commission publishes a notice confirming the module’s functionality. Until these obligations apply, the provisions of the corresponding Directives remain in force, covering vigilance, clinical investigations, registration of devices, and certificate notifications (Q2).
Actors and devices subject to EUDAMED registration obligation
All actors that need to perform any actions on EUDAMED need to be registered in the ACT module. This includes the following economic operators also (Q4):
- System or procedure pack producers (SPPPs)
- Manufacturers who exclusively place custom-made devices on the market
- Manufacturers who exclusively place class III custom-made implantable devices on the market
- Sponsors of clinical investigations and performance studies
Distributors are not required to register in EUDAMED (Q5).
The UDI/DEV module (device module) is active since October 2021. Currently, device registration is voluntarily but highly recommended (Q9). Once mandatory, the device registration in the device module must be completed before the first unit is placed on the EU market. This registration applies to all subsequent units with the same UDI-DI. Custom-made devices, investigational devices and devices for performance studies should not be registered in the device module (Q7). Additionally, legacy devices do not need to be registered if the same device is already registered as a Regulation device. Importantly, devices subject to changes which would lead to the assignment of a new UDI-DI would not be considered as the same device (Q8).
Certificates, vigilance, and market surveillance modules
The NB/CRF module (the certificates’ module) has been available since October 2021 and notified body can already register the certificates. Its use is voluntary (Q11). On the contrary, the VGL (vigilance) module – to be used by manufacturers and/or authorised representative – is not available for voluntary use. For vigilance reports initiated under national processes before the VGL module becomes mandatory, it will still be necessary to transition to EUDAMED once it becomes obligatory to use the module. However, retrospective registration of the initial report in EUDAMED is not necessary (Q13).
Lastly, the MSU module (market surveillance) is not available. Once available, its access will be restricted to competent authorities and notified bodies only (Q15 and 16).
Do you have questions on EUDAMED registrations? Contact us here.
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