EUDAMED reaches a major milestone with 4 modules now fully deployed
The European Commission has confirmed that four components of the European Database on Medical Devices (EUDAMED) are now fully operational and meet all technical and regulatory requirements set out under the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Regulation (EU) 2017/746.
This development marks a major advancement in the EU’s strategy to enhance oversight of medical technologies, reinforcing transparency, device traceability, and regulatory accountability across the market.
The modules that have reached full functionality are:
Registration of Economic Operators
UDI/Device Registration Database
Notified Bodies and Certificates
Market Surveillance
According to Decision (EU) 2025/2371 – released in the Official Journal on 27 November 2025 – the transition timelines for the mandatory use of these tools have officially commenced.
The obligation to use these four EUDAMED modules will apply starting 28 May 2026.
In the meantime, manufacturers and stakeholders are encouraged to familiarize themselves with the system and ensure that their data processes are ready for integration into EUDAMED.
This milestone underscores the European Union’s ongoing commitment to improving patient protection and harmonizing regulatory practices throughout the medical device ecosystem.
