The EU Parliament has also adopted the proposal regarding the gradual roll-out of EUDAMED which will facilitate the launch of parts of the Database. This means that the mandatory use of several parts of EUDAMED will start from as early as Q4 of 2025/Q1 of 2026. This gradual roll-out of EUDAMED will help increase transparency and provide an overview of the medical devices on the EU market.
Just a reminder, under the old legislation, EUDAMED would have become mandatory when all 6 modules are functional, which due to some delays in the development of the module for clinical investigations/performance studies, would be late 2029.
Currently, three of the six modules have been available for use on a voluntary basis by manufacturers, however, our experience shows that there is still some resistance among manufacturers to register on EUDAMED.
Are you ready for these changes? Should you need any assistance with Actor/Device Registration on EUDAMED, please don’t hesitate to contact us.
More information can be found using the following link
