Since October 1, 2026, importers have been able to link their actor registration to devices already registered in the Swiss database. Swissmedic provides a transitional period until April 1, 2027.
At a glance
- The update: importers can now link themselves to devices in swissdamed.
- The distinction: importers link their actor registration to existing device registrations, without registering the devices again.
- The deadline: from April 1, 2027, Swissmedic will no longer accept delays between placing an imported device on the market and linking it in swissdamed.
- The cost: linking is free of charge.
Actor registration and device registration
Swissdamed distinguishes between information about economic operators and information about devices.
The Actors module manages economic operator registrations. The CHRN — Swiss Single Registration Number is assigned by Swissmedic to identify operators unambiguously. It is issued to Swiss importers, among other economic operators.
The UDI Devices module covers device registration and management. Swissmedic’s user guide distinguishes this activity from the linking performed by importers.
There are therefore three distinct elements: identifying the operator, registering the device in the database, and establishing a link between the two.
What does linking a device mean?
Linking is based on the UDI-DI, the device identifier, and associates the importer with an existing registration in swissdamed.
According to Swissmedic’s user guide, the device must have been registered previously by the authorised representative, foreign manufacturer, or foreign person who assembles systems and procedure packs. It must also have the status “On the market”.
The importer does not create a new device registration: it links its actor registration to the existing device record.
The user guide describes functions for linking individual UDI-DIs or groups of identifiers, checking existing links, and removing them using the unlink function.
Understanding the different deadlines
Registration of devices, systems, and procedure packs has been mandatory since July 1, 2026, with a general transitional period until December 31, 2026, subject to any applicable specific provisions.
For importer linking, Swissmedic specifies April 1, 2027. During the transitional period, the authority will not take enforcement measures solely because a link is missing. This period does not extend the general device registration deadline.
A specific deadline of November 1, 2028 applies to Master UDI-DI assignment, registration, and linking for spectacle frames, spectacle lenses, and ready-to-wear reading spectacles.
How does swissdamed relate to EUDAMED?
Swissmedic has aligned the structure of swissdamed with EUDAMED to facilitate the reuse of data prepared by economic operators.
This alignment does not involve automatic synchronisation. The official webpage states that there is no interface through which Swissmedic can directly import or synchronise data from EUDAMED.
Device information must therefore be actively uploaded to swissdamed using the available methods. Registration in EUDAMED does not, by itself, constitute registration in the Swiss database.
Why this development matters
The new functionality enables importers to establish links between their actor records and the records of devices they place on the Swiss market.
The central point is the relationship between distinct activities: linking requires the device registration to be available first. Understanding this sequence helps clarify both the responsibilities described by Swissmedic and the different deadlines, without confusing actor registration with device registration.
Official sources
- Swissmedic — Importers
- Swissmedic — Registering economic operators (CHRN)
- Swissmedic — Device registration
- Swissmedic — swissdamed Support / User Guide UDI Devices Module
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Informational note
This article is for informational purposes only and does not constitute regulatory, legal, technical, or professional advice. For applicable requirements, deadlines, and procedures, please refer to the official texts and current Swissmedic documentation.