Software as a Medical Device (SaMD)
Software intended by the manufacturer for use in humans for medical purposes; under MDR and IVDR, such software is itself a medical device and can be the Annex I product under Condition (a), second alternative, of Article 6(1), so the AI system IS both the AI system and the regulated product.
Defined in 3 GAGE programs, which carry 3 distinct definitions of it. The wording above is taught in EU AI Act Implementation Expert.
How each discipline defines it
The same term does different work depending on who is using it. These are the definitions as each program teaches them, unedited.
Software intended by the manufacturer for use in humans for medical purposes; under MDR and IVDR, such software is itself a medical device and can be the Annex I product under Condition (a), second alternative, of Article 6(1), so the AI system IS both the AI system and the regulated product.
The FDA's regulatory category for software, including AI- and machine-learning-enabled tools, intended for one or more medical purposes without being part of a hardware medical device, subject to premarket review and adverse-event reporting.
Software, including many clinical AI tools, that performs a medical function and is regulated by the FDA, typically requiring validation and evidence of safety and effectiveness before market.
Where it is taught
The exact lessons this term appears in. The first 7 topics of every program are free with a free account.
- AI Liability: Product Liability, Section 230, and Tort Evolution · Legal Frameworks and Liability Navigation, The AI Lobbyist: Certified AI Policy Strategist
- The Compliance-First Transformation Playbook · Lab: Regulated Industries, Certified AI Transformation Professional (CATP)
- Annex I Integration: AI in Regulated Products · AI System Inventory and Classification, EU AI Act Implementation Expert
Terms it appears with
Not an alphabetical neighbourhood: these are the terms taught in the same lessons, ranked by how often they appear together.