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.Examples
- An AI system used in a medical imaging device to detect subtle anomalies for cancer screening, where inaccurate detection could lead to missed diagnoses or unnecessary procedures.
- An AI-powered algorithm embedded in a robotic surgical system that assists with precision movements, classifying as high-risk due to its direct safety component role in a Class IIb medical device.
- A clinical decision support system that provides diagnostic or therapeutic recommendations based on patient data, if it directly impacts treatment outcomes and is subject to third-party conformity assessment under the MDR.
- •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.
Latest in MedTech
Sources
3 sourcesEvery citation below opens the original document. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1Regulation (EU) 2024/1689, Article 6Tier 1 VerifiedEUR-Lexeur-lex.europa.eu
- 2Commission Q&A on the AI ActTier 2 UncheckedEuropean Commissiondigital-strategy.ec.europa.eu
- 3IMDRF DocumentsTier 2 VerifiedIMDRFimdrf.org
Inline markers like [1] jump to the matching reference above.