The European Commission has announced a delay of the full functionality of the European database on medical devices (EUDAMED) and a new update of the platform’s development timeline. This timeline includes a delay of one year on the remaining steps required for EUDAMED full functionality and applicability. This is key information of economic operators, as the registration obligations related to EUDAMED become fully mandatory now of EUDAMED total functionality. It is important to note that authorities advise to already use the active modules. Even if the timeline to comply – starting from the publication in the Official Journal of the EU that EUDAMED is fully functional – is set at 6 months (actor registration) and 24 months (device registration, including legacy devices, which in case of incidents or FSCA shall be completed at that very moment)
New EUDAMED planning
In first place, completion of the module development process in the database has been postponed to Q3 2024. In the new timeline issued, not-yet-active modules (vigilance, clinical investigation and market surveillance) will have to be incorporated to the database at the end of 2023. The previous forecast indicated that all modules would be accessible in Q4 of 2022, while the new expected finalization is Q2 2024.
Moreover, an audit on EUDAMED will be conducted during the first quarter of 2024. Afterwards, the MDCG will assess the results of the audit. If the results of this audit are positive, the Commission will publish a notice in the Official Journal of the European Union. This action will lead to the release of the full EUDAMED system, therefore in that moment EUDAMED will become fully functional.
Source of the image: European Commission
As indicated previously, please note that after the notice publication in the OJEU, transitional periods will be triggered. The use of EUDAMED will become mandatory 6 months after the OJEU notice publication for requirements related to:
- Clinical Investigation & Performance Studies
- Market Surveillance
In the case of the following areas, the use of EUDAMED will become mandatory 24 months after the OJEU notice publication:
- Notified Bodies