The EUDAMED database is delayed by two years
The European Commission has announced that the new pan-European database, EUDAMED, will be delayed by two years.
The central pan-European database, EUDAMED, which will improve the control with and surveillance of marketed medical devices and in-vitro diagnostical devices in Europe was expected to be ready in March 2020. This date has now been postponed by two years, as several of the modules of the database are not fully functional. The European Commission now expects companies to be able to start uploading information on medical devices to the database in March 2022, which is also the planned timeline for upload of information on in-vitro diagnostical devices.
EUDAMED will replace the previous database Eudamed2 and the new database will, among other things, contain information on producers of medical devices and in-vitro diagnostical devices, authorised bodies and any damage caused by the devices. The development of EUDAMED is part of adoption of the new EU regulations on medical devices and in-vitro diagnostical devices which come into force in all of EU in 2020 and 2022, respectively.
You can read more about EUDAMED here
You can read more about the new EU regulations within this area here