swissdamed, the Swiss Database on Medical Devices, is managed by Swissmedic and serves as the official registry for economic operators and medical devices, including in vitro diagnostic devices, on the Swiss market. It is intended to give a transparent overview of available devices and the companies behind them, such as manufacturers, authorized representatives, and importers.
What’s New?
Until now, swissdamed only offered the Actors module, where economic operators (manufacturers, authorized representatives, and system/procedure pack assemblers) could register and update their details.
With the launch of the UDI Devices module, economic operators can now register:
- Medical devices
- In vitro diagnostic (IVD) medical devices
- Systems and procedure packs
This new functionality will play a crucial role in providing a clear picture of which devices are available on the Swiss market — and who is responsible for them.
From Voluntary to Mandatory
Device registration in swissdamed is voluntary for now, but that will change soon.
- 1 July 2026: Registration becomes mandatory for all devices and systems/procedure packs placed on the Swiss market.
- 31 December 2026: Transitional period ends.
- Exceptions: Devices linked to serious incidents, field safety corrective actions, or trend reporting must be registered immediately from 1 July 2026, with no transitional period.
Who Needs to Register?
Registration applies to:
- Swiss manufacturers
- Authorized representatives
- Those assembling systems and procedure packs
Each of these groups is responsible for ensuring their devices (or mandated devices) are correctly registered in swissdamed.
Alignment with the EU (But No Direct Link)
To reduce the burden on companies working across borders, Swissmedic has designed swissdamed to closely align with the EU’s EUDAMED system. Device data prepared for EUDAMED can largely be transferred to swissdamed.
However, there is no direct interface between the two databases. This means data cannot be imported or synchronized automatically. Economic operators must actively upload device data themselves. Currently, uploads can be done via XML files in the EUDAMED “GET DEVICE” or “POST DEVICE” format, with additional upload options (like machine-to-machine transfer) planned for the future.
Rollout Timeline at a Glance
- August 2024 – swissdamed launched with the Actors module
- August 2025 – UDI Devices module opened for voluntary registration
- 1 July 2026 – Mandatory device registration begins
- 31 December 2026 – Transitional period ends
Next Steps
With swissdamed’s rollout underway, economic operators should begin preparations now to ensure compliance ahead of the 2026 deadlines.
