The EU commission is proposing making some of the EUDAMED modules mandatory at an earlier stage, by Quarter 4 of 2025. Under the current legislation, EUDAMED will become mandatory when all 6 modules are functional, which due to some delays in the development of the module for clinical investigations/performance studies, would be late 2029. Under this new proposal, EUDAMED modules will be rolled out gradually and become mandatory once the modules have been audited and declared as functional.
This move is seen as important due to the fact that EUDAMED is vital for the implementation of MDR and IVDR and is of high value to National Competent Authority who will be able to monitor the medical device market more effectively such as gathering important information regarding potential product shortages. In addition, the deployment of EUDAMED has many advantages for the manufacturer as it will help them save time and resources by preventing multiple registrations or instances of communication of data on a national level.
Implementing this proposal would also mean that the transitional provisions in the MDR and IVDR pertaining specifically to EUDAMED would need to be amended to allow the smooth transfer from multiple registrations in national databases to a singular registration in EUDAMED.
Three of the six modules have been available for use on a voluntary basis by manufacturers, however, our experience shows that there is still some resistance among manufacturers to register on EUDAMED.
If you need assistance in acquiring your Single Registration Number (SRN) we can take on the responsibility of submitting on behalf of the manufacturer their Actor Registration, once the process is complete the manufacturer is issued by the Competent Authority their SRN.
Additionally, If you require help in adding all the necessary information to the EUDAMED UDI-DI Device Registration module we have a service that will help ease the burden, it is time-consuming so you may find this beneficial.
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