From 1 July 2026, manufacturers of medical devices and IVDs on the Swiss market will have to ensure that their devices are registered in Swissdamed. Swissdamed is the national database managed by Swissmedic, the Swiss competent authority.
This deadline brings new operational and compliance obligations for Swiss Authorised Representative and for manufacturers that sell devices in Switzerland.
What changes on 1 July 2026?
As of 1 July 2026, the use of the swissdamed UDI/Device module becomes mandatory. From this date, all medical devices, IVDs, systems, and procedure packs placed on the Swiss market must be registered in Swissdamed, including device benefiting from legacy status.
This obligation follows the earlier implementation of the Actor module, which has been operational since August 2024 for the registration of economic operators.
Transition period until end of 2026
Swissmedic has provided a transitional period until 31 December 2026 to allow economic operators to complete device registrations. However, important exception applies:
- Devices subject to vigilance obligations (serious incidents, field safety corrective actions and trend reporting) must be registered without delay. The transition period does not apply.
Who must register?
The registration obligation applies primarily to:
- Swiss manufacturers
- Swiss Authorised Representatives (CH‑REPs)
- Producers of systems and procedure packs
For non-Swiss manufacturers, compliance requires the appointment of a Swiss Authorised Representative, who will register their devices and IVDs.
If you place medical devices on the Swiss market, this deadline applies to you.
Contact us here for any questions.
References:
Swissmedic (2026). swissdamed – swiss database on medical devices. Retrieved on 11/06/2026.
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