EUDAMED with its six modules was planned as an important cornerstone for the implementation of Regulations (EU) 2017/745 and 2017/746 on medical devices (MDR) and in vitro diagnostic medical devices (IVDR). EUDAMED was originally planned to be fully operational with the first date of application of the MDR.
Several delays were communicated in the past years – the last update provided for an expected date of full operation in 2024.
Now it seems the date by which the medical device database is due to be recognized as fully functional, and the date by which reporting into the database is due to be mandatory, look likely to be postponed yet again.
If the draft EUDAMED Roadmap presented at the recent European Commission’s Medical Device Coordination Group meeting will be put into practice, the date of full operation will be postponed until mid-2027! Accordingly, use of the EUDAMED modules would not be mandatory until 2029.
Reasons for the potential delay are not enough resources and the lack of readiness of the clinical investigations module.
The legal situation requires EUDAMED to have all six modules ready until full functionality can be claimed. Experts call for a practical approach where full functionality can be confirmed already at an earlier stage. If this won’t happen, this would mean that even though the modules on actor registration, UDI/device registration, and on notified body certificates are sufficiently ready to have already been launched on a voluntary basis, they will not be officially launched. As a result, economic operators will face further years of staggered timelines to be considered and a patchwork of local registration requirements.
Source: Medtech Insight (an Informa product)