Currently, the EC database on medical devices, Eudamed2, is a secure web-based portal. It is a central repository for information on market surveillance exchanged between national competent authorities and the Commission. Its use is restricted to national competent authorities, it is not open for consultation and is not publicly accessible.
However, the new medical devices regulations contain important improvements including a much larger EUDAMED database. The new EUDAMED will be multipurpose. It will function as a registration system, a collaborative system, a notification system, a dissemination system (open to the public), and will be interoperable.
What is the state of play of the implementation of EUDAMED?
- The development and implementation of EUDAMED is a high priority for the Commission.
- We have pledged, in agreement with the MDCG, to gradually make the different modules available as soon as they are functional.
- We will make the module on actor registration available first, deploying it by March 2021 at the latest.
- We will make the module on UDI/device registration (second module) and the module on certificates and notified bodies (third module) available by May 2021. The remaining modules will become available afterwards as soon as they are functional.
We update the documents below under ‘functional specifications’, ‘MDR/IVDR UDI and device’, and ‘data exchange’ as new information becomes available. Please check back regularly for the latest versions as they are subject to adjustments and fine-tuning.