With the publication on 27th November 2025 (Commission Decision (EU) 2025/2371 of 26. November 2025, OJ L, 2025/2371, 27.11.2025) the European Commission confirmed that the modules "Actor registration", "UDI/Device registration", "Notified Bodies and Certificates", and "Market Surveillance" of the EUDAMED database are functional and meet the functional specifications.
Therefore, the registration of EU economic operators (manufacturers, importers, authorized representatives), devices, and systems and procedure packs that are placed on the market in the EU will be mandatory in EUDAMED as of May 28, 2026. A transition period applies until November 27, 2026.
In Switzerland, the registration of economic operators has already been in place since November 26, 2021, and has been available in swissdamed since August 2024.
The registration of devices, systems, and procedure packs will become mandatory in swissdamed as of July 1, 2026, with a transition period until December 31, 2026 (amendment to the Ordinance on In Vitro Diagnostic Medical Devices of November 20, 2024, AS 2024 742, only available in German, French and Italian: Änderung der Verordnung über In-vitro-Diagnostika vom 20. November 2024, AS 2024 742).
The product registration requirement in swissdamed will thus take effect in Switzerland approximately one month after the EU. Economic operators are requested to consider these deadlines and plan the registration of their devices, systems, and procedure packs accordingly.