What EU AI Act (EU) 2024/1689 - Article 43: Conformity Assessment Procedures for High-Risk AI Systems requires
Article 43 specifies two conformity assessment routes for high-risk AI systems before market placement. Route 1 (internal control - Annex VI): providers self-assess against AI Act requirements; applies to all high-risk AI systems in Annex III EXCEPT biometric identification, critical infrastructure, education, employment, essential services, law enforcement, migration/asylum, and administration of justice categories. Route 2 (notified body assessment - Annex VII): mandatory third-party conformity assessment by an accredited EU notified body; applies to: (a) real-time remote biometric identification systems; (b) high-risk AI systems that differ substantially from any system for which conformity assessment was previously conducted under a harmonised standard. When a subsequent version of an already-certified system includes modifications not covered by the previous certificate, a new assessment is required. Providers may choose a more stringent procedure than the minimum required.
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: 795849e218e79326588d96cc12cfcd7770b7d67809ca7653b328d85d53137e40
Primary Citations — 8 traced to source
- Article 43 — EU AI Act (EU) 2024/1689 - Article 43: Conformity Assessment Procedures
- Annex VI — EU AI Act (EU) 2024/1689 - Annex VI: Internal Control Procedure
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