Software as a Medical Device (SaMD)
Overview
Software is explicitly included in the MedDO definition. Standalone software intended for a medical purpose is regulated as a medical device in its own right. Qualification guidance MDCG 2019-11 applies in Switzerland.
Qualification — Does This Software Qualify as a Medical Device?
Key qualification tests (MDCG 2019-11):
- Does the software perform an action on data beyond storage/archival/communication/search? → Potentially a medical device
- Does its output drive clinical management or treatment decisions? → Likely a medical device
- Is its output solely for administrative purposes? → Generally not a medical device
Classification of SaMD
Apply the 22 MedDO classification rules, especially Rule 11 and Rule 22. Software IVDs use IVDO Annex VIII Rule 7. Typical classes: Class I (low-risk information to professionals), IIa (medium-risk decision support), IIb (high-risk diagnostic decisions), III (life-critical closed-loop control).
IEC 62304 — Software Lifecycle
MedDO Annex I § 17 requires software to be developed in accordance with the state of the art. IEC 62304 defines software safety classes A/B/C and development, maintenance, and change management requirements for each class.
AI and Machine Learning
Swissmedic follows MDCG guidance on AI/ML. Key points: AI/ML software with medical intended purpose is regulated as a medical device; training/validation datasets must be documented; algorithm updates may constitute significant changes requiring new conformity assessment.
Official Sources
AI-assisted content for navigation only. Always verify against official Swissmedic and Fedlex sources. Not legal or regulatory advice.