What REGULATION (EU) 2024/1689 (Artificial Intelligence Act) - Article 43: Conformity assessment procedures for high-risk AI systems requires
This article mandates specific conformity assessment procedures for providers of high-risk AI systems, determining when an internal control assessment is sufficient versus when a third-party notified body must be involved.
Pillar: AI Governance & Law · Authority: European Parliament and Council of the European Union · Version: 1.0.1 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32024R1689
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- Article 43(2): For high-risk AI systems referred to in Article 6(1) and listed in Annex III, points 2 to 8, providers shall follow the conformity assessment procedure based on internal control (Module A) as referred to in Annex VI, which does not provide for the involvement of a notified body.
- Article 43(3): For high-risk AI systems referred to in Article 6(1) and listed in Annex III, point 1, providers shall follow the conformity assessment procedure based on an assessment of the quality management system and an assessment of the technical documentation (Module H) as referred to in Annex VII, with the assessment being carried out by the notified body that the provider has chosen in accordance with Article 31.
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