What EU AI Act (EU) 2024/1689 - Article 40: Harmonised Standards and Presumption of Conformity for High-Risk AI Systems requires
Article 40 establishes the presumption of conformity mechanism for high-risk AI systems: a system that complies with harmonised European standards (EN standards) published in the Official Journal of the EU is presumed to conform with the corresponding EU AI Act requirements covered by those standards. This is the primary conformity pathway for providers who want to avoid the cost and time of notified body assessment for requirements covered by harmonised standards. The European Commission mandates CEN/CENELEC to develop AI-specific harmonised standards. Where harmonised standards do not yet exist, providers may rely on Commission-adopted Common Specifications per Article 41. Standards applicable to other EU legislation (e.g., ETSI EN 303 645 for IoT cybersecurity) may also contribute to presumption of conformity for overlapping requirements.
Pillar: AI Governance & Law · Authority: European Parliament and the Council of the European Union · Version: 2.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32024R1689
SHA-256 integrity: 604a5dfb3376095c6eb07972c4bc892f847bc66b9c20c57363e24588f49be493
Primary Citations — 8 traced to source
- Article 40 — EU AI Act (EU) 2024/1689 - Article 40: Harmonised Standards
- Article 41 — EU AI Act (EU) 2024/1689 - Article 41: Common Specifications
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