Swissmedic has launched the Unique Device Identification (UDI) module within the swissdamed database (Swiss Database on Medical Devices). Since August 2025, manufacturers, importers, and authorized representatives can voluntarily submit medical devices, systems, and procedure packs into swissdamed.
This launch marks a major step in Switzerland’s medical device regulatory framework. It also brings swissdamed closer to the European Union’s EUDAMED system. The UDI module will improve traceability, increase transparency, and strengthen post-market surveillance.
Key Points from Swissmedic
- Voluntary Phase (August 2025):
Submissions to swissdamed are optional during this period but are strongly recommended to prepare stakeholders for future mandatory requirements. - Mandatory Timeline:
From July 1, 2026, device registration in swissdamed will be mandatory. A transition period will apply until December 31, 2026, after which compliance will be required. - Submission Format:
Swissmedic follows EUDAMED standards. Organizations can upload an EUDAMED XML extract directly into swissdamed, reducing duplication for companies already complying with EU regulations. - Future Integration:
In the second half of 2026, machine-to-machine (M2M) integration will enable automated data exchange between company systems and swissdamed.
Implications for Stakeholders
The UDI module represents a significant regulatory advancement for Switzerland. Although participation is voluntary now, early engagement will ease adoption once registration becomes mandatory.
Organizations should:
- Review internal processes
- Ensure data quality
- Prepare for XML-based submissions aligned with EUDAMED
Proactive involvement during the voluntary phase will reduce operational risks, highlight technical challenges, and ensure readiness for the 2026 compliance deadlines.
For further guidance on preparing for swissdamed and leveraging existing EUDAMED processes,
download our comprehensive EUDAMED whitepaper.
