European database on medical devices (EUDAMED)
The European Commission has recently set up a new webpage to collect information that is related to the implementation of the upcoming European database on medical devices (EUDAMED). The website is expected to be updated regularly upon new implementation documents are finalised.
Posted on 06.06.2019
For the moment, the following information is posted:
- Latest version of the Eudamed functional specifications (v4.1)
- MDR UDI and device data sets and IVDR UDI and device data sets to be registered in Eudamed and the UDI and device data dictionary
- Data exchange guidelines and
- a set of documents related to Machine-to-machine (M2M) data exchange
The informational webpage is available here.