Three different timelines are operating in swissdamed
Swissmedic has been rolling out swissdamed in stages. The Actors module has been used for economic-operator registration since 2024, while the UDI Devices module opened for voluntary device registration in 2025. Mandatory device registration then began on 1 July 2026.
The important distinction is that 1 July did not create every swissdamed obligation at once. Economic-operator registration, device registration, importer linking, and vigilance-triggered registration each follow a different timeline.
Economic-operator CHRN registration predates 1 July 2026
Swiss manufacturers, authorised representatives, importers, and persons who assemble systems and procedure packs must register with Swissmedic and obtain a Swiss Single Registration Number (CHRN) before placing devices on the Swiss market.
Swissmedic states that economic-operator registration has been in place since 26 November 2021 and has been available through the swissdamed Actors module since August 2024.
A CHRN identifies the economic operator; it is not the device-registration identifier.
Device registration became mandatory on 1 July 2026
Devices, IVDs, systems, and procedure packs placed on the Swiss market are now subject to mandatory registration in the UDI Devices module of swissdamed.
For the general population of affected devices, a transition period runs through 31 December 2026. Devices already on the market before 1 July that continue to be placed on the market after that date must also be registered within the transition period.
After the transition period, devices generally need to be registered before they are placed on the market.
Vigilance-triggered devices do not get the year-end transition period
Swissmedic applies immediate registration from 1 July 2026 for devices, systems, and procedure packs for which a serious incident, field safety corrective action, or trend must be reported.
This does not mean the vigilance report itself has moved into the swissdamed device-registration module. The practical point is that the affected device cannot wait until 31 December to be registered in swissdamed once the vigilance reporting obligation is triggered.
Who does what in swissdamed
Swiss manufacturers, persons who assemble systems and procedure packs, and authorised representatives can register devices in the UDI Devices module.
For foreign manufacturers, the Swiss authorised representative typically manages the device registration for the devices covered by its mandate.
Importers have a different task. They do not register devices themselves. Instead, they link their importer actor to a UDI-DI that has already been registered by the manufacturer, authorised representative, or another permitted registering actor.
Importer linking has its own rollout
The importer-linking requirement is tied to the mandatory device-registration framework, but Swissmedic is rolling out the technical linking function in stages.
Swissmedic states that the importer-linking function will not be available until autumn 2026. Importers are nevertheless expected to prepare by keeping their Actors module information current, identifying the relevant devices, and collecting the information required for later linking.
Once the function is available, affected importers are expected to catch up their linking by 1 April 2027. From that date, Swissmedic states that a delay between placing an imported device on the market and completing the link will no longer be tolerated.
What companies can check now
- Confirm that the CHRN status and actor data for Swiss manufacturers, authorised representatives, and importers are current.
- Build a registration plan for current and legacy devices that will continue to be placed on the Swiss market through the end of 2026.
- Define who owns the UDI/device-registration activity for each product: manufacturer, authorised representative, or system/procedure-pack assembler.
- Make sure the vigilance process triggers an immediate swissdamed device-registration check whenever a serious incident, FSCA, or trend report occurs.
- Prepare importer UDI-DI lists now so that linking can be completed after the technical function becomes available.
The practical compliance task is to separate actor identity, device identity, and supply-chain linking. CHRN registration identifies the economic operator, the UDI Devices module registers the device, and importer linking connects the importer to that registered device. Vigilance events can accelerate the device-registration deadline and should therefore be built directly into the company’s post-market and registration workflows.
Sources
- Primary official sourceswissdamed – swiss database on medical devices (opens in a new tab)Swissmedic, Swiss Agency for Therapeutic Products
- Supporting sourceDevice registration (opens in a new tab)Swissmedic, Swiss Agency for Therapeutic Products
- Supporting sourceRegistering economic operators (CHRN) (opens in a new tab)Swissmedic, Swiss Agency for Therapeutic Products
- Supporting sourceImporters (opens in a new tab)Swissmedic, Swiss Agency for Therapeutic Products
- Supporting sourceDeadline for Device Registration in swissdamed (opens in a new tab)Swissmedic, Swiss Agency for Therapeutic Products