EUDAMED Now Mandatory: Update on National Requirements and Resources
28 May 2026
May “In All Other News”: swissdamed Webinar, AI Act Postponed, & More
2 June 2026Background
Swissmedic has implemented a registration database called swissdamed, which mirrors EUDAMED. It becomes mandatory starting 1 July 2026, followed by a six-month transition period. All devices and systems/procedure packs must be entered into the system by 31 December 2026. The only exceptions are the same as for EUDAMED, e.g., custom-made devices do not require registration in EUDAMED or swissdamed.
Swissmedic previously advised that fees would be due for swissdamed registration, and that more information would be provided in due course:
The Update
Swissmedic published its new fees for swissdamed device registration: HERE
The final deadline to register all devices marketed in Switzerland, is 31 December 2026. As of this date, any device registered in swissdamed as “on the market” will be subject to an annual registration fee:
- CHF 200 for the first device per year and CHF 20 for each additional device
- A maximum of CHF 10,000 per year per manufacturer / person who assembles systems or procedure packs (no additional costs for 492 devices or more per year)
The first invoice will be issued in January 2027. Any devices newly registered after this date are also subject to this fee.
This is part of their cost-recovery efforts, as Swissmedic currently operates at a loss.
Swissmedic hosted a webinar on swissdamed 28 May 2026, in which they discussed the new fee structure. Swissmedic advised:
- The recording from the above training will be shortly published.
- A second training will be provided in November 2026 (registration not yet open).
Casus will share a link to the May recording and future November 2026 training session, once available.
