Agentic Fluxus · MDR / IVDR + EU AI Act integrated assessment
Healthcare AI Dual Conformity Checklist
Medical AI is the cleanest example of multi-regime stacking under EU product law. AI qualifying as a medical device under MDR 2017/745 (or as an IVD under IVDR 2017/746) is Annex I embedded high-risk under the AI Act — both regimes apply. This checklist sequences the dual conformity work.
Pre-conformity: classification
- Confirm MDR / IVDR class (I / IIa / IIb / III) based on risk.
- Confirm Annex I embedded high-risk under the AI Act.
- Identify the notified body able to perform integrated assessment.
Conformity assessment integrated
- MDR technical documentation completed (Annex II / III MDR).
- AI Act Annex IV technical documentation completed (overlap with MDR documentation reuse permitted).
- Quality management system per ISO 13485 covers AI lifecycle.
- Clinical evaluation includes AI-specific safety + performance evidence.
- Article 14 AI Act human-oversight measures integrated with clinical-validation protocols.
Post-market vigilance
- MDR vigilance under Articles 87-92 (2 / 10 / 15 day clock).
- AI Act Article 73 reporting on the same clock to the national MSA.
- Coordinated submission permitted: one notification feeds both regimes.
- Hospital-deployer chain notification per Article 26(5).
Article 4 literacy for clinical staff
- Every clinician using AI tools has received AI literacy training proportionate to role.
- Training integrated with continuing medical education (CME) systems.
- Per-AI competence recorded against individual clinical credentials.
Deadline
Annex I embedded high-risk obligations apply from 2 August 2028 (delayed from 2 August 2026 by the Omnibus deal of 7 May 2026).
Read the healthcare AI guide:
https://agenticfluxus.com/blog/eu-ai-act-for-healthcare
By John Ferguson · Founder, Agentic Fluxus · agenticfluxus.com · Amsterdam, Netherlands