Swissmedic Activates swissdamed Importer Linking

Swissmedic made the importer linking function available in swissdamed on 1 October 2026. Swiss importers must now link their actor registration to the UDI-DIs of the devices, systems, and procedure packs they place on the Swiss market, and Swissmedic has set a transitional period until 1 April 2027 to complete this. Because linking only works for devices that are already registered, the requirement directly depends on manufacturers and Swiss authorized representatives (CH-REPs) completing device registration on time. Full details are available on the Swissmedic swissdamed Importers page. For background on the database itself, read our post How to Submit Data to swissdamed and How It Differs from EUDAMED.

Background

Under Article 53(4) of the Medical Devices Ordinance (MedDO) in conjunction with Article 13(4) of the EU MDR, and Article 46(4) of the In Vitro Diagnostic Medical Devices Ordinance (IvDO) in conjunction with Article 13(4) of the EU IVDR, importers must add their own details to a registered device that they place on the market. In swissdamed, this is not done through device registration. Importers instead link their actor record, identified by their Swiss Single Registration Number (CHRN), to the UDI-DI of a device that has already been registered.

Device registration in the swissdamed UDI Devices module has been mandatory since 1 July 2026. Manufacturers, persons who assemble systems and procedure packs, and authorized representatives must register devices, systems, and procedure packs by 31 December 2026. When registration became mandatory, the importer linking function was not yet available. Swissmedic has now released it, together with an updated swissdamed User Guide for the UDI Devices Module (BW630_40_841e, 1 October 2026).

Key Points

• What changed: The technical function that allows importers to link themselves to registered devices has been available in swissdamed since 1 October 2026.
• How linking works: Linking is based on the UDI-DI. It is only possible for devices already registered in swissdamed with the status “On the market”. Importers can link UDI-DIs individually or by bulk upload of up to 1,000 UDI-DIs per operation, and can cancel a link with the unlink function.
• Who is responsible: Importers are responsible for linking all relevant devices, systems, and procedure packs to their CHRN and for keeping their contact details in the Actors module accurate and up to date at all times.
• Transitional period: Importers have until 1 April 2027 to complete linking. Until that date, Swissmedic will not take enforcement measures solely because a link is missing.
• After the transition: From 1 April 2027, Swissmedic will no longer accept any delay between placing an imported device on the Swiss market and its linkage in swissdamed.
• Device registration deadline: Manufacturers, CH-REPs, and persons who assemble systems and procedure packs must register devices by 31 December 2026. Importers cannot link a device that has not been registered. Devices subject to a serious incident, field safety corrective action (FSCA), or trend report must be registered immediately, without a transitional period.
• Eyewear exception: For spectacle frames, spectacle lenses, and ready-to-wear reading spectacles, a later deadline of 1 November 2028 applies for Master UDI-DI assignment, registration, and linkage.
• What does not change: Importers do not register devices in swissdamed themselves, and linking does not replace any other importer obligation under the MedDO or IvDO. Swissmedic confirms that importers incur no costs for linkage.

Broader Implications

The importer deadline sits at the end of a chain. An importer can only link a UDI-DI once the manufacturer or CH-REP has registered it and set its status to “On the market”. In practice, a gap in device registration becomes a gap in importer compliance, even where the importer is ready to act.
Accurate data exchange is the most likely point of failure. Importers need the exact UDI-DIs registered in swissdamed for the products they import, and those must match what is actually shipped. Where a manufacturer works with more than one Swiss importer, or where product portfolios change frequently, a clear and current UDI-DI list per importer will save time on both sides. From 1 April 2027, new devices entering the Swiss supply chain will need to be registered and linked without delay, so this is a process to set up, not a one-time exercise.
There is no interface between swissdamed and EUDAMED, so device and actor data registered in EUDAMED does not satisfy Swiss requirements. Manufacturers active in both markets should manage swissdamed registration and importer coordination as a separate workstream from their EUDAMED obligations.

What This Means for Manufacturers

• Complete swissdamed device registration: Confirm that all devices, systems, and procedure packs on the Swiss market are registered by 31 December 2026, with the status “On the market”.
• Share UDI-DI lists with your Swiss importers: Provide each importer with the registered UDI-DIs for the products they import, so they can link individually or by bulk upload.
• Align timelines with your CH-REP and importers: Agree when registration will be complete so importers can finish linking before 1 April 2027.
• Plan for new products: Set up a routine so that new or changed UDI-DIs are registered and communicated to importers before the devices are placed on the Swiss market.
• Check the eyewear exception: If your portfolio includes spectacle frames, spectacle lenses, or ready-to-wear reading spectacles, confirm whether the 1 November 2028 deadline applies.
• Join the Swissmedic webinar: Swissmedic is hosting a free online swissdamed webinar on 10 November 2026 covering device registration, importer linking, fees, device transfers, and data downloads. Places are limited, and a recording will be published afterward.

How MedEnvoy Can Support 

MedEnvoy shares this update as part of our regulatory intelligence service, which monitors Swissmedic and other authorities for changes that affect device registration, market access, and post-market obligations. The swissdamed importer linking requirement connects the work of manufacturers, CH-REPs, and importers, and gaps in any one link affect the whole supply chain.
As a Swiss Authorized Representative, MedEnvoy can register your devices in swissdamed, verify their registration status, and help you prepare the UDI-DI information your Swiss importers need for linking. Where MedEnvoy also acts as your Swiss importer, we link your registered UDI-DIs to our CHRN in swissdamed, so registration and linking are managed by one partner. We also support gap assessments of your swissdamed data and coordination of timelines ahead of the 31 December 2026 and 1 April 2027 deadlines. Contact us to discuss how we can support your Swiss market access.