Digital Health & SaMD
Software, AI/ML systems, and connected medical devices are regulated as medical devices in Switzerland where they meet the MedDO intended purpose criteria. This section covers the Swiss regulatory framework for digital health products.
| Page | Covers |
|---|---|
| Swissmedic's Digital Health Framework | Strategic overview; Swissmedic's approach to digital health regulation |
| Software as a Medical Device — Overview | Qualification, classification, and lifecycle requirements for SaMD in Switzerland |
| AI/ML Medical Device Guidance | AI/ML-specific regulatory considerations; algorithm lifecycle; Swissmedic expectations |
| Cybersecurity in Switzerland | IEC 81001-5-1; MDCG 2019-16; pre- and post-market cybersecurity obligations |
| MDCG 2019-11 Applicability | SaMD qualification guidance in the Swiss context |
Disclaimer
AI-assisted navigation aid only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.