High-Risk AI System (EU AI Act)
AI systems captured by Article 6 of the EU AI Act because they are safety components of regulated products or listed in Annex III.
Definition
Under Article 6 of Regulation (EU) 2024/1689, an AI system is high-risk if it is a safety component of, or itself is, a product covered by Union harmonisation legislation listed in Annex I (which includes medical devices under the MDR and IVDR) and requires third-party conformity assessment, or if it is listed in Annex III. Nearly all AI-enabled Class IIa and above medical devices fall into the first branch.What this means in practice
For MedTech, this means the AI Act does not create a separate CE mark: obligations layer on top of the MDR/IVDR conformity assessment through the notified body. Manufacturers must satisfy Articles 8 to 15 (risk management, data governance, technical documentation, record-keeping, transparency, human oversight, accuracy, robustness, and cybersecurity) in addition to the underlying device regulation.- •Assuming Class I MDR devices with AI escape the AI Act. Many still do, but only where no third-party conformity assessment is required.
- •Treating the AI Act as a replacement for MDR Annex XVI clinical evaluation. It is additive, not substitutive.
- •Confusing Annex III (standalone high-risk use cases) with the MedTech route through Annex I.
Frequently asked questions
Related terms
Grouped by themeEditor's picks
· Hand-selected related conceptsRegulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.
Regulation (EU) 2017/745 governing medical devices in the European Union.
EU-designated organization that assesses conformity of medical devices under MDR and IVDR.
EU regulation establishing risk-based requirements for AI systems, including most medical AI.
More in Regulatory
· Same categoryFDA submission demonstrating a device is substantially equivalent to a legally marketed predicate.
Two alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Where this term appears across MedTech Terms.
Primary references
3 sources- 1
Regulation (EU) 2024/1689, Article 6VerifiedEUR-Lexeur-lex.europa.eu
- 2
Commission Q&A on the AI ActUncheckedEuropean Commissiondigital-strategy.ec.europa.eu
- 3
IMDRF DocumentsVerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.