The Swissdamed platform continues to take shape – and with it the regulatory obligations for manufacturers and distributors of medical devices in Switzerland and Liechtenstein. A central module is now in focus: the UDI Devices module, which will bring far-reaching changes for the medical technology industry from 2026.
📌 What specifically is changing?
From 1 July 2026 , the registration obligation for UDIs (Unique Device Identifiers) will become mandatory. This innovation affects all players in the medical device industry:
Obligation to register for all products:
- All products, systems and treatment units must be registered in Swissdamed before being placed on the market for the first time
- This obligation applies to both products placed on the market in Switzerland and Liechtenstein
- UDI registration becomes a prerequisite for legal placing on the market
⏳ Transitional regulation provides planning security
Companies will receive a transitional period until December 31, 2026. This six-month period makes it possible to subsequently register existing products in Swissdamed and adapt internal processes accordingly.
Use this time for:
- Systematic recording of all products subject to UDI requirements
- Adjustment of internal registration processes
- Training of employees
- Technical integration into existing systems
⚠️ No deadline for vigilance reports – immediate action needed
Critical exception: No transitional period applies in the following cases – here the immediate registration obligation applies from 1 July 2026:
- Reporting a serious incident
- Field Safety Corrective Action (FSCA)
- Trend Messages
These vigilance cases require prior registration of the affected UDI data in Swissdamed. Further information on vigilance reports can be found at: swissmedic.ch > Medical devices > Reporting incidents & FSCAs (vigilance)
🔍 Special regulations for “Old Devices”
Special regulations apply to products that were already on the market before 1 July 2026. Swissmedic provides detailed information in an FAQ section:
👉 swissmedic.ch > Medical devices > swissdamed > Questions and answers
🔄 Future functionalities
The search for UDI-DI and medical device data within the Swissdamed database has been announced for a future release, but is not yet available. This feature will further simplify the work with the platform and increase the efficiency of the product search.
💡 Strategic recommendations for companies
Start preparing now:
- Inventory of all products subject to UDI requirements
- Evaluation of existing vigilance processes
- Technical evaluation for system integrations
- Scheduling for step-by-step registration
Minimizing risk through early planning: A proactive approach helps minimize compliance risks and avoid potential market disruptions.
Your partner for UDI implementation
Europe IT Consulting will be happy to support you with structured UDI acquisition, conversion and data transmission – also for Swissdamed. Our expertise includes:
- Technical system integration
- Automated data conversion
- Compliance Consulting
- Process optimisation
- You can find more information about Swissdamed here: Swissdamed UDI
For specific questions about implementation in your company, contact our team of experts.
Stay informed about further developments of the Swissdamed platform and regulatory changes in the medical technology industry.
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