Since the MRA with the EU has not been updated, Swissmedic does not have access to the European database EUDAMED3. As a result, since 26 May 2021 Swiss economic operators (manufacturers, importers and authorised representatives) have had to register with Swissmedic in order to obtain a unique registration number (Swiss Single Registration Number – CHRN).
When the Actors module goes live on 6 August 2024 for the registration of economic operators, the current practice will change.
Forms to end on 26 July 2024
Applications for registration and for changing the CHRN, as well as notifications for mandates, will continue to be accepted as PDF forms until 26 July 2024 (submission date). After that date, these forms will no longer be considered.
What happens from 6 August 2024?
The Actors module of swissdamed will be available from 6 August 2024. Thereafter, economic operators will be registered exclusively through application via www.swissdamed.ch.
The e-mail inbox CHRN@swissmedic.ch will be replaced by an online contact form.
What happens from August 2024 for operators who are already registered?
The data for the almost 3,700 economic operators who have already registered with Swissmedic, and therefore possess a CHRN, will be migrated. At the start of August, the registered operators will be informed by letter, via the contact person stated to us during registration, about what happens next. They will not need to register again; they will simply have to check their data once these have been imported into swissdamed.
Device registration
In June 2024, a group of manufacturers and the agencies that issue UDIs were invited to test the first upload options for devices. In 2025, Swissmedic plans to make available the first sections of swissdamed for the registration of certain devices on a voluntary basis.
The compulsory registration of medical devices, incl. IvD medical devices, on the Swiss market is planned at a later date. The aim is to improve transparency, provide information about devices on the Swiss market and, for the first time, maintain an overview of the available range of devices.