In August 2025, Swissmedic announced the new UDI Devices module in Swissdamed is live. The registration is voluntary and will become mandatory only in July 2026. Switzerland is rolling out the different modules of the data gradually. The actor module is available from August 2024 and is for registration of Swiss manufacturers, importers, authorised representatives, and manufacturers of systems and procedure packs.
Medical devices registration in Switzerland: timelines
The UDI module can be used to register medical devices, in vitro diagnostic medical devices, and systems and procedure packs. From 1 July 2026, the registration will be mandatory for devices placed on the market in Switzerland. The transitional period will go until end of 2026.
Devices subject to a reporting obligation for serious incidents, field safety corrective actions or trend will not have a transitional period and have to be registered by 1 July 2026.
Obligations to register with Swissdamed
The actors subject to device registrations are Swiss manufacturers, persons who assemble systems and procedure packs, and authorised representatives. Authorised representatives must register their mandated devices, as well as systems and procedure packs. Importers do not register devices in Swissdamed. However, they are required to add their data to a registered device that they place on the market.
Once mandatory, Swissdamed will charge a one-time fee for registering devices. Currently, information of the fee amount is not yet available.
Do you need more information? Submit your questions about device registration here or at mdlaw@obelis.net.
References:
Swissmedic (2025). New in swissdamed: Medical device registration now available. Retrieved on 18/08/2025.
Swissmedic (2025). Swissdamed – Swiss database on medical devices. Retrieved on 18/08/2025.
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