Swissdamed (Swiss Database on Medical Devices)

Swissdamed is the official medical device registration database managed by Swissmedic, Switzerland’s medical device regulator. The primary objectives of swissdamed are to improve traceability, enhance regulatory oversight, and ensure public access to verified information about medical devices marketed in Switzerland. It is used by Swissmedic and economic operators (manufacturers, importers, authorized representatives) to monitor device status and compliance.

It is modeled closely on the EU’s EUDAMED system but includes Swiss-specific regulatory requirements and fields. There is no interoperability between the two systems. Registration must be conducted independently.

Swissdamed Registration Requirements

• Actor Registration: Required before any device can be registered. Foreign manufacturers cannot access swissdamed directly; their CH-REP must register on their behalf and obtain a Swiss Single Registration Number (CHRN). All Swiss-based manufacturers, authorized representatives (CH-REPs), importers, and system/procedure pack producers must register in the Actor Module.
• Device Registration: All devices sold in Switzerland must be registered using the UDI Devices module, including Basic UDI-DI, UDI-DI, device characteristics, intended purpose, risk class, and nomenclature codes.

Swissdamed Mandatory Use Deadlines

• 1 July 2026: Device registration becomes mandatory, with no transition period for devices involved in vigilance actions.
• 31 December 2026: End of the transition period for all remaining devices.

Can non-Swiss manufacturers register directly in swissdamed?

No. Non-Swiss manufacturers must appoint a Swiss Authorized Representative (CH-REP), who is responsible for registering the manufacturer in the Actor Module and obtaining a Swiss Single Registration Number (CHRN) on their behalf.

What is a CHRN?

The CHRN (Swiss Single Registration Number) is a unique identifier assigned to each economic operator registered in swissdamed. It is required to complete device registration and is used to track regulatory responsibilities within the Swiss market.

When does device registration in swissdamed become mandatory?

Device registration becomes mandatory on 1 July 2026. There is a transition period until 31 December 2026 for most devices, except those involved in vigilance actions, which must be registered without delay beginning 1 July 2026.

Is swissdamed the same as EUDAMED?

No. There is no direct link between swissdamed and EUDAMED. Manufacturers must submit data to each system separately. However, XML files used for EUDAMED registration may be reused in swissdamed if they conform to the appropriate schema.

What types of devices must be registered in swissdamed?

All medical devices, IVDs, and system/procedure packs intended for the Swiss market must be registered in the UDI Devices Module by the applicable deadlines.

Are there fees associated with swissdamed registration?

Yes. Swissmedic charges an annual device-registration fee based on the number of devices recorded in swissdamed on 31 December. The fee is CHF 200 for the first device and CHF 20 for each additional device, capped at CHF 10,000 per year. Swissmedic states that the first invoices will be issued from January 2027 based on the database status at 31 December 2026. Confirm the current amounts and billing rules on Swissmedic's official registration-fee page.