Obligations of importers in swissdamed
According to Art. 53 para. 4 MedDO in conjunction with Art. 13 para. 4 EU-MDR and according to Art. 46 para. 4 IvDO in conjunction with Art. 13 para. 4 EU-IVDR, importers are obliged to add their own details to a registered device that they place on the market.
These details are added not via a device registration, but by linking the importer (actor) to the corresponding device in swissdamed. This linking is based on the UDI-DI and is possible only if the device has been registered in swissdamed in advance by the authorised representative (AR) or by its foreign manufacturers or foreign persons who assemble systems and procedure packs.
Important: Importers do not register any devices in swissdamed themselves. They merely link their actor to devices that have already been registered.
Mandatory registration and linking
Mandatory registration from 1 July 2026
As of 1 July 2026, mandatory registration will apply to devices and systems and procedure packs placed on the Swiss market.
Manufacturers (MF), persons who assemble systems and procedure packs (PR), authorised representatives (AR) and their foreign manufacturers or foreign persons who assemble systems and procedure packs must register devices, systems and procedure packs by 31 December 2026.
Technical linking: Availability and deadlines
All devices that are placed on the market, and therefore linked, by importers, must have been registered correctly in Swissmedic beforehand.
Swissmedic points out that the technical function to link importers with devices registered by manufacturers will be rolled out in stages. Although the mandatory registration will apply from 1 July 2026, the linking function for importers in swissdamed will not be available until Autumn 2026.
However, the importers concerned will still be required to take all reasonable preparatory steps, particularly to update their own details in the Actors Module, identify the devices concerned and have the information required for the subsequent linking to hand.
During the technical introduction phase, Swissmedic will not take any enforcement measures solely due to a missing link, provided the missing link is attributable exclusively to the non-availability of the technical linking function. After making the function available, Swissmedic then expects the linking processes to be updated by the importers by 1 April 2027.
In this phase, Swissmedic will provide information explaining the linking process for importers. Swissmedic assumes that the phase from Autumn 2026 to 1 April 2027 will be sufficient to comply with the linking requirements. Thereafter, all devices, systems and procedure packs that are placed on the Swiss market by importers will have to be linked. A delay between the placing on the market of the imported device and the linking will not be tolerated with effect from 1 April 2027.
Special case
For the following eyewear products, a later deadline of 1 November 2028 applies in for Master UDI-DI assignment, registration and linking:
- Spectacle frames
- Spectacle lenses
- Ready-to-wear reading spectacles
Information and support from Swissmedic
In Autumn 2026, Swissmedic will provide comprehensive information on the introduction of the linking function. Registered importers will receive detailed information directly by e-mail and will have access to it via this website.