Article 43Chapter III — High-Risk AI Systems
Conformity Assessment
High-Risk
Summary
Defines the conformity assessment procedures applicable to high-risk AI systems. Most systems use internal control (Annex VI), while biometric systems and critical infrastructure require third-party assessment (Annex VII).
Keywords
conformity assessmentnotified bodyinternal controlthird-party
Legal Text
Article 43 — Conformity Assessment 1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider has applied harmonised standards referred to in Article 40, or, where applicable, common specifications referred to in Article 41, the provider shall follow one of the following procedures: (a) the conformity assessment procedure based on internal control referred to in Annex VI; (b) the conformity assessment procedure based on assessment of the quality management system and assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.
All Articles
Quick Actions