The gradual roll-out of Swissdamed continues as October 2026 brings two new functions:
- Linkage of importers to the devices they import.
- Automatic expiration of mandates signed between foreign manufacturers and Swiss Authorised Representatives (CH-REP).
Importer obligations
If you are a Swiss importer, you are obliged to link your actor registration to all UDI-DIs you place on the Swiss market by 1 April 2027. As of that day, the linkage on Swissdamed will have to be done prior to placing the device on the market. The obligation applies to medical devices, systems and procedure packs, and in-vitro diagnostics.
Eyewear devices subject to Master UDI-DI assignment (spectacle frames, spectacle lenses, ready-to-wear reading spectacles) have a later deadline of 1 November 2028.
Manufacturer obligations
If you are a manufacturer, ensure that your devices are registered on Swissdamed in due time before their placement on the market, or within the transition period (if applicable) to grant your importer sufficient time to link the device to their account.
- The use of the Swissdamed device module is mandatory since 1 July 2026. From this date, all medical devices, IVDs, systems, and procedure packs placed on the Swiss market must be registered in Swissdamed.
- The transition period ends on 31 December 2026 and does not apply to devices subject to vigilance obligations.
CH-REP mandate validity
Foreign manufacturers are required to appoint CH-REP by a written mandate. The mandate’s details must be registered on Swissdamed by the CH-REP, including the validity start- and end date. As of October, any mandate outside the validity period will be marked as invalid and devices listed therein must not be placed on the market.
If you are a manufacturer, make sure to keep your CH-REP informed of any changes and your mandate updated.
Contact us here for any questions.
References:
Swissmedic. (2026). Release notes. Retrieved on 15 October 2026.
Swissmedic. Importers. Retrieved on 15 October 2026.
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