Swissmedic has activated the swissdamed UDI Devices module, marking a significant step toward mandatory medical device registration in Switzerland. While use of the system is currently voluntary, all medical devices, IVDs, and procedure packs must be registered by 1 July 2026.
Switzerland’s Swissmedic has introduced the swissdamed UDI Devices module for medical device registration. Since August 2024, swissdamed has served as the national database for medical devices, and now it supports registration of medical devices, in vitro diagnostic devices (IVDs), and procedure packs. While use of the module is currently voluntary, it will become mandatory from 1 July 2026 for all devices placed on the Swiss market.
Swissmedic has rolled out the swissdamed UDI Devices module to strengthen regulatory oversight. Companies can now register:
This phased approach allows manufacturers and other operators to adapt before the 2026 compliance deadline.
Registration applies to specific economic operators, including:
The new swissdamed requirements align Switzerland more closely with international UDI systems, improving traceability, safety, and transparency. Companies that prepare early will benefit from smoother compliance and avoid last-minute bottlenecks before the 2026 deadline.
To stay compliant:
Switzerland’s Swissmedic requires medical devices, IVDs, and procedure packs to be registered in swissdamed. The UDI Devices module, launched in 2025, is voluntary until 1 July 2026, when registration becomes mandatory. Obligations apply to Swiss manufacturers, authorised representatives, and system assemblers. The update improves traceability and aligns Switzerland with global UDI systems.
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