On its website on the European database on medical devices (EUDAMED), the European Commission has declared a new timetable for the new Eudamed medical device database.
According to the Commission, some of the modules for the new Eudamed 3 database will be in operation about the same time as Regulation (EU) 2017/745 on medical devices (MDR) fully applies on 26 May 2021.
It is planned that:
- the ‘actor’ registration modules will be available by March 2021,
- the module on UDI and device registration will become available once they are operating, probably by May 2021 and
- the Notified Body certificates module will also be available by May 2021.
The Commission has also declared that it is intending to publish a position paper on the use of the actor registration module and on the issuing of the Single Registration Number (SRN), a crucial tool, by the end of June this year.
There is currently no information available by when the remaining modules on vigilance, market surveillance and clinical investigations will be ready. But the Commission declared that it still plans for Eudamed 3 to become fully functional in 2022.
Sources: European Commission website, Medtech Insight (an Informa product)
Accompanying this subject we recommend the following content on this website
- Our article “Device Registration and Legacy Devices“.
- Our article “News on EUDAMED”.
- Our article “Early access to Single Registration Numbers (SRN)”.