Summary
Updated Medical Device Coordination Group guidance on when software, including AI/ML functions, qualifies as a medical device and how to classify it under Medical Device Recognition/In Vitro Diagnostic Regulation. Clarifies decision steps, borderline cases, and alignment with other MDCG docs; adds examples and notes on updates/versions.
Healthcare Implications
Essential reference for determining if clinical AI is Software as a Medical Device and for assigning class, which governs evidence and oversight. Product and regulatory teams should map features against the decision tree and classification rules to scope clinical evidence and Post-Market Surveillance/Post-Market Clinical Follow-up (PMCF).