[2025-08-15] Swissmedic, the Swiss Agency for Therapeutic Products, updated its “swissdamed” page on August 15, 2025. Swissdamed is the database for the registration of economic operators and medical devices, including in vitro diagnostic medical devices, on the Swiss market.
Context
The web page reminds us that swissdamed consists of two modules: the “Actors” module (for the registration of economic operators) and the “UDI Devices” module (for the registration of devices). The “Actors” module went online on August 6, 2024 (see previous network article).
In order to maintain maximum consistency with European regulations, and to limit the administrative burden for companies, swissdamed has adopted the structure of the equivalent modules of the European EUDAMED database. However, the two databases remain independent. Data must be deposited separately in both databases.
News and calendar
An implementation schedule is now available:
From July 1ᵉʳ, 2026, registration will be mandatory for all devices, systems and procedure packs placed on the Swiss market.
A transitional phase is planned until December 31, 2026.
For all devices that have to be notified to Swissmedic following a serious incident, corrective action or trend, registration becomes immediately mandatory from July 1, 2026, with no further delay.
Related documentation
The page also features a new swissdamed user guide for the “UDI Devices” module (reference BW630_40_841, version 1.0, dated 15/08/2025). This is a 17-page didactic document, with numerous screenshots. It details the complete process for uploading, registering, validating, updating, managing the status of registered devices, versioning, deleting or transferring Unique Device Identifiers (UDIs).
It should also be noted that the swissdamed user guide for players was also updated on the same date (BW630_40_001, version 1.3, dated 08/15/2025). This update includes the addition of CHRN (unique registration number) cancellation/deletion, mandate transfer, and a general reorganization of content.
Conclusion
With swissdamed, Switzerland continues its regulatory harmonization with the EU, while maintaining its management autonomy.
Article written by Lam-Xé NOEL, Managing Director of DM Experts SAS