What EU AI Act Article 40 - Harmonised Standards and Presumption of Conformity requires
EU AI Act Regulation 2024/1689 Article 40 establishes that high-risk AI systems complying with harmonised standards adopted pursuant to Regulation (EU) 1025/2012 and cited in the Official Journal are presumed to conform with the corresponding requirements of Chapter III Section 2 (Articles 8-15) - providers can use harmonised standards as the primary technical compliance pathway, with the Commission mandating European standardisation organisations (CEN/CENELEC) to develop AI-specific harmonised standards; where no relevant harmonised standards exist or where standards do not fully cover the requirements, common specifications under Article 41 may supplement or replace the harmonised standard pathway.
Pillar: AI Governance & Law · Authority: European Commission · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689
SHA-256 integrity: dca446c781452abc2af964c6d7a149515de5bb3df3a9f56b32e87083e13e0c33
Primary Citations — 5 traced to source
- {"title":"Regulation (EU) 2024/1689 - Article 40: Harmonised Standards","url":"https://eur-lex.europa.eu","relevance":"Primary EU AI Act provision establishing harmonised standards as the primary technical compliance pathway for Chapter III Section 2 high-risk AI system requirements - Article 40 creates the legal presumption of conformity mechanism that is the fundamental compliance route for providers seeking to demonstrate conformity with Articles 8-15 requirements"}
- {"title":"Regulation (EU) 2024/1689 - Article 41: Common Specifications","url":"https://eur-lex.europa.eu","relevance":"EU AI Act fallback compliance pathway applicable where no harmonised standards exist or where harmonised standards do not fully cover Chapter III Section 2 requirements - common specifications under Article 41 are adopted by Commission implementing act and create the same presumption of conformity as harmonised standards where applicable"}
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