EU Regulatory Readiness for Health AI Vendors
7 modules · 0 completed · ≈ 5 h 20 min
Modules
From product facts to a defensible regulatory starting point
EU Regulatory Readiness for Health AI Vendors
A complete vendor track for health AI teams. Seven modules take you from a stable product picture, through qualification and classification reasoning, to a conformity strategy, a clinical evidence plan, the EU AI Act overlay and a QMS and lifecycle plan — assembled into a Regulatory Readiness Blueprint v1.0 you can hand to your advisers. It structures regulatory reasoning; it never concludes device status, framework applicability, class, route or readiness.
Map Your Product
Before asking what class you are, build a stable picture of the thing you are regulating: the regulatory unit and its dependencies, the input → processing → output → user → action chain, generated versus pass-through information, patient-specific routes, supported configurations, use context, and the claims your company actually controls.
Is It a Medical Device?
Turn the fact base into a disciplined qualification assessment: intended purpose as the regulatory anchor, the EU Medical Device Regulation (MDR) Article 2(1) medical-purpose families, the Medical Device Coordination Group (MDCG) software qualification sequence, device and accessory linkage, the specimen-gated MDR/In Vitro Diagnostic Medical Devices Regulation (IVDR) boundary, and a red-team pass over the story before you rely on it.
Understand Your Likely Classification
How MDR classification is reasoned and documented: intended purpose governs classification, independent software is classified in its own right, the strictest applicable rule wins, Rule 11(a) decision impact, Rule 11(b) monitoring, the narrowness of 11(c), competing rules and linked devices — ending in a learner-authored preliminary classification position, never an automated class.
Plan Your Conformity Strategy
How conformity assessment is structured and what it demands of a small software manufacturer: Article 52 route logic by class, technical documentation as a traceable chain, what a notified body does and does not do, and which workstreams your working position sets in motion — ending in a learner-authored Conformity Strategy Worksheet with an explicitly preliminary route hypothesis.
Build Your Clinical Evidence Plan
Claim → evidence → gap → action, claim by claim: valid clinical association, technical and analytical performance, clinical performance, what literature and internal validation can and cannot carry, prospective and live evidence, and how to name a gap precisely enough to fund it — ending in a learner-authored Clinical Evidence Plan.
Add the EU AI Act Layer
Three questions kept apart — the MDR/IVDR question, the AI Act question, and what can serve both: provider, deployer and value-chain roles, the Article 6 routes into the high-risk regime, the transparency and general-purpose layers that apply independently, and the reuse/extend/new map — ending in a learner-authored AI Act Overlay with an explicitly preliminary high-risk hypothesis.
Build Your QMS & Lifecycle Plan
The operating system behind everything you have written, learned through a change-impact exercise: quality-management processes and owners, design and change control for software that ships continuously, supplier and foundation-model dependencies, post-market surveillance, PMCF, vigilance and CAPA — ending in a learner-authored QMS & Lifecycle Plan and the assembled Regulatory Readiness Blueprint v1.0.