Swissdamed: key information and deadlines for manufacturers of medical devices

In Switzerland, Swissmedic enforces the registration of Swiss economic operators and medical device with Swissdamed. Swissdamed (Swiss Database on Medical Devices) has two modules: actor module and device/UDI module. The actor module is available from August 2024, while the device module is available from August 2025.

CHRN number: Swiss Single Registration Number

The CHRN, the Swiss Single Registration Number, is an identification number assigned by Swissmedic. Upon approval of a registration request, actors receive a confirmation e-mail containing the CHRN. This identification number is issued to Swiss manufacturers, authorised representatives and importers, and to manufacturers of systems and procedure packs.

Registrations submitted before Swissdamed availability

Economic actor registrations notified to Swissmedic before Swissdamed became available in August 2024 have been migrated into the new system and no new registration should be required. Affected economic operators were contacted  by the Swiss competent authority.

Registration mandatory from 1 July 2026

The device registration obligation becomes mandatory on 1 July 2026. After this date, medical devices, IVDs, systems, and procedure packs placed on the Swiss market must be registered by 31 December 2026 (transitional period). There is no transitional period for devices, IVDs, systems, and procedure packs for which a serious incident, field safety corrective action, or trend must be reported to Swissmedic. In such cases, devices must be registered immediately, starting from 1 July 2026.

Swissdamed and EUDAMED: are both registrations necessary?

Switzerland and the European Union have two separate legislative frameworks for medical devices and thus, two different databases. The two databases are not interconnected and both registrations are necessary when medical devices are sold in both territories.  For the same reason, manufacturers outside of Switzerland or Lichtenstein must appoint a CH-REP if they want to place their devices on the Swiss market. Similarly, Swiss manufacturers must appoint a EU-REP if they want to place their devices on the Union market.

Do you have questions on registrations of medical devices and IVDs? Contact us today here.

Regulatory Intelligence & Innovation
09/10/2025

Reference:

Swissmedic (2025). Swissdamed – swiss database on medical devices. Retrieved on 09/10/2025.

Swissmedic (2025). Swissdamed – Questions and answers. Retrieved on 09/10/2025.

The information contained on obelis.ch is presented for general information purposes only, without obligation and it has been compiled with the utmost care to ensure it remains up to date. Nevertheless, Obelis Group cannot be held liable for the accuracy and completeness of the information published. Any reliance placed on such information is therefore strictly at the User’s risk.

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