- Features
- Legal basis
- Swissdamed vs. EUDAMED
- Schedule and implementation phases
- Impact on manufacturers
- References
What is Swissdamed?
Swissdamed is the central Swiss database for medical devices, which was developed as a national counterpart to the European EUDAMED database. The platform serves as a central hub for all regulatory information on medical devices placed on the market in Switzerland and Liechtenstein.
Main purpose and functions
Swissdamed fulfils several central functions in the Swiss medical device ecosystem:
Central registration and monitoring:
- Recording of all medical devices before they are placed on the market
- Tracking of Unique Device Identifiers (UDIs)
- Monitoring of security events and vigilance messages
- Management of certificates and conformity assessments
Transparency and market access:
- Creating transparency for authorities, healthcare providers and the public
- Simplifying market access through standardised processes
- Assistance with product identification and traceability
Regulatory background and legal basis
Swiss medical device law
The legal basis for Swissdamed is the Therapeutic Products Act (HMG) and the associated regulations:
Primary law:
- Federal Act on Medicinal Products and Medical Devices (Therapeutic Products Act, HMG) of 15 December 2000
- SR 812.21 – Systematic collection of federal law
Prescription law:
- Medical Device Ordinance (MepV) of 1 July 2020
- SR 812.213 – Ordinance on Medical Devices
- Ordinance on in vitro diagnostic medical devices (IVDV) of 1 July 2020
International harmonisation
Switzerland has largely aligned its medical device law with EU regulation:
EU
alignment:
- Orientation to the Medical Device Regulation (MDR) 2017/745
- Harmonization with the In Vitro Diagnostic Regulation (IVDR) 2017/746
- Mutual Recognition Agreement (MRA) between Switzerland and the EU
Already 🔄 using EUDAMED?Then you benefit twice over: our tools support both EUDAMED and Swissdamed – consistent data, less effort.
Differences from other European databases
Swissdamed vs. EUDAMED
| Aspect | Swissdamed | EUDAMED |
|---|---|---|
| Scope | Switzerland & Liechtenstein | EU Member States |
| Legal basis | Swiss HMG/MepV | EU MDR/IVDR |
| Implementation | Modular since 2023 | Gradually since 2020 |
| Languages | German, French, Italian | All official EU languages |
| UDI system | Mandatory from July 2026 | Already implemented |
Special features of the Swiss solution
National adjustments:
- Consideration of the Liechtenstein market (EEA Agreement)
- Integration into the Swiss admission system
- Adaptation to national vigilance processes
- Coordination with Swissmedic as national authority
Schedule and implementation phases
Importance for the medical technology industry
Impact on manufacturers
Compliance Requirements:
- Mandatory pre-entry registration
- Continuous data refresh
- Integration into existing QM systems
- Training of employees
Business benefits:
- Simplified market access through digital processes
- Improved product traceability
- Strengthening trust with customers and authorities
- International harmonisation of data structures
Healthcare Benefits
For healthcare providers:
- Better product identification in everyday clinical life
- Simplified vigilance messages
- Access to up-to-date safety information
- Support with purchasing and warehouse management
For patients:
-
- Increased product safety through better monitoring
- Transparency about medical devices used
- Faster response to security issues
👉 Ready for Swissdamed registration?Our solution for automated UDI data transmission is specially designed for Swissdamed – for SAP and Excel users.
Further information
Official Sources
- Swissmedic – Swiss Institute for Therapeutic Products
- Swissdamed portal (if available)
- Federal Office of Public Health (FOPH)
Legal bases
International References
For specific questions about implementation in your company, contact our team of experts.
