EUDAMED, finally!

Commission Decision (EU) 2025/2371 was published in the Official Journal of the European Union on November 27, 2025, officially announcing the full operation of the first four modules of the Eudamed database:

  1. “Actors” module, for the registration of economic operators (manufacturers, importers, authorized representatives, and manufacturers of systems and procedure kits)
  2. “UDI/Devices” module, for the registration of medical devices
  3. Notified Bodies and Certificates
  4. Market Surveillance

The timeline is now defined, and in six months, at the end of the transitional period provided for by Regulation (EU) 2024/1860, and therefore starting May 28, 2026, the use of these modules will become mandatory.

By that date, manufacturers must:

  • be registered as actors on EUDAMED,
  • register their devices and their UDIs in the database,
  • ensure the uploaded data is constantly updated.

The Eudamed project is not yet complete. In addition to the four modules that are about to become mandatory, two more are planned, currently still under development:

  • the module dedicated to Vigilance
  • the module relating to Clinical Investigations and Performance Studies

The latest timeline, dated November 27, 2025, foresees the publication in the Official Journal of the European Union of the full functionality of the last two modules at the end of 2026, and therefore their mandatory use by spring 2027. At that point, the Eudamed database will conclude its very long gestation period and, more than 10 years after the project’s launch, will become the central European database for medical devices as required by Regulation (EU) 2017/745 (MDR) on Medical Devices and Regulation (EU) 2017/746 (IVDR).

Those involved in the transition process to mandatory EUDAMED use must now make an immediate effort to adapt and adopt the necessary strategies for assigning UDIs, translating them, implementing clear and timely market surveillance, and ensuring timely registrations. It’s easy to imagine that in the coming months, between Eudamed requirements and the ever-shortening timeframes for transitioning to MDR certification for Legacy Devices, activities will significantly accelerate and the workload will increase for all stakeholders, particularly for manufacturers’ PRRCs and QA/RAs, who will be required to respond promptly to meet the upcoming regulatory and legislative deadlines fully prepared!