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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 applies MDCG guidance on AI/ML; Switzerland is not an EU member and Swissmedic independently assesses AI/ML devices as medical devices under MedDO requirements. Key requirements: AI/ML software with medical intended purpose is regulated as a medical device; training/validation datasets must be fully documented with provenance, representativeness, and limitations disclosed; algorithm updates, retraining with new data, or significant performance changes may constitute modifications requiring reassessment or post-market surveillance notifications.