What EU AI Act Annex VII - Third-Party Conformity Assessment by Notified Bodies for High-Risk AI Systems requires
EU AI Act Regulation 2024/1689 Annex VII establishes the third-party conformity assessment procedure based on assessment of quality management system and assessment of technical documentation, conducted by notified bodies designated under Articles 31-39 - this procedure applies mandatorily to high-risk AI systems intended for biometric identification under Article 43(1) and optionally to providers of other high-risk AI systems who choose third-party certification; the Annex VII procedure consists of two parts: Part A (quality management system assessment and certification), and Part B (assessment of technical documentation); successful completion of both parts results in the notified body issuing a certificate of conformity that supports the provider's EU declaration of conformity and CE marking.
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: 3554973470ed6810828714055e208c66fc69830883918cceaa04b20bcfe7b67d
Primary Citations — 5 traced to source
- {"title":"Regulation (EU) 2024/1689 - Annex VII: Conformity Assessment Based on Assessment of Quality Management System and Assessment of Technical Documentation","url":"https://eur-lex.europa.eu","relevance":"Primary EU AI Act Annex establishing the third-party conformity assessment procedure for high-risk AI systems - Annex VII specifies the Part A (QMS assessment) and Part B (technical documentation assessment) procedures that notified bodies must follow when certifying high-risk AI systems, and the provider obligations for facilitating and maintaining the assessment"}
- {"title":"Regulation (EU) 2024/1689 - Article 43(1): Conformity Assessment for Biometric Identification AI Systems","url":"https://eur-lex.europa.eu","relevance":"EU AI Act provision mandating the Annex VII third-party conformity assessment for high-risk AI systems intended for biometric identification of natural persons - Article 43(1) specifies that the Annex VII procedure is mandatory for this category and voluntary for other Annex III categories"}
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