What EU AI Act - Conformity Assessment Procedures for High-Risk AI Systems (Articles 43-49) requires
EU AI Act (Regulation 2024/1689) Articles 43-49 establish the conformity assessment framework that high-risk AI system providers must complete before placing their systems on the EU market; two conformity assessment tracks apply: (1) Article 43(1) mandatory third-party notified body assessment - applies to high-risk AI systems listed in Annex III Point 1 (biometric identification and categorisation systems) and to high-risk AI systems governed by Union harmonisation legislation in Annex I (medical devices, machinery, civil aviation, vehicles, personal protective equipment, in vitro diagnostic devices, rail interoperability, maritime equipment, lifts) where the relevant sectoral legislation already requires third-party assessment; notified bodies are independent conformity assessment bodies accredited by national accreditation bodies and notified to the European Commission; (2) Article 43(2) internal control self-assessment - applies to all other Annex III high-risk AI systems not covered by Article 43(1); under internal control, the provider verifies the AI system's compliance with Articles 8-15 requirements and draws up the technical documentation without third-party review; Article 47 provides for the EU declaration of conformity - providers must draw up a signed written declaration stating the high-risk AI system complies with the EU AI Act requirements; Article 48 establishes CE marking obligations - CE marking must be affixed to high-risk AI systems (or their accompanying documentation) before market placement, visibly, legibly, and indelibly; Article 49 requires registration of high-risk AI systems in the EU database for high-risk AI systems before placing on the market; conformity assessment must be completed before first market placement; providers must initiate a new or updated conformity assessment where the AI system undergoes substantial modification after market placement; the conformity assessment framework applies to providers established outside the EU who place high-risk AI on the EU market, who must appoint an authorised representative under Article 22.
Pillar: AI Governance & Law · Authority: European Parliament and Council of the EU · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32024R1689
SHA-256 integrity: e99a20b0f9dc848caee9722261cc04837bd8893981a4d40213f2995b80f52f53
Primary Citations — 5 traced to source
- Regulation (EU) 2024/1689 - EU AI Act: Article 43 - Conformity Assessment
- Regulation (EU) 2024/1689 - EU AI Act: Article 47 - EU Declaration of Conformity
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