On August 18, 2025, Swissmedic announced the launch of the new UDI Devices module in the swissdamed database. This marks an important step towards greater transparency in the Swiss market.
What’s new?
- Medical devices, IVDs, and systems/procedure packs can now be registered in swissdamed
- Registration is voluntary for now, but will become mandatory from July 1, 2026
- A 6-month transition period applies, except for devices subject to vigilance reporting, which must be registered by July 1, 2026 without transition
- Obligations apply to Swiss manufacturers, authorized representatives, and assemblers of systems/procedure packs
Supporting (new and updated) documents published by Swissmedic include:
- User Guide for Actors (registration, CHRN, role management)
- Business Rules (data submission, aligned with EUDAMED but Swiss-specific)
- Quick Guides (public search, UDI registration steps)
- UDI Devices Module User Guide (uploading, validating, updating UDIs)
- Privacy Notice & Terms of Use (data handling and user rights)
- Service Agreement (legal framework, responsibilities, fees).
The documents list is published here: https://lnkd.in/e6exeq7S.
How Qserve can support you
With regulatory landscapes evolving rapidly, understanding how these changes impact your business is crucial.
That’s where Qserve InSight comes in. Our Regulatory Intelligence service keeps you updated on global changes, helping your organization stay compliant, competitive, and prepared for upcoming requirements such as swissdamed registration.