Chapter IIIHigh-Risk
Article 43
Conformity Assessment
Plain-Language Summary
Defines the conformity assessment procedures applicable to high-risk AI systems. Most systems use the internal control procedure (Annex VI). Biometric identification systems and systems in Annex II products require third-party assessment by a notified body (Annex VII).
Keywords
conformity assessmentAnnex VIAnnex VIIinternal controlnotified bodybiometricprocedure
Legal Text
Article 43 — Conformity Assessment 1. For high-risk AI systems listed in point 1 of Annex III, where, in demonstrating 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 as 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, as referred to in Annex VII. 2. For high-risk AI systems referred to in points 2 to 8 of Annex III, providers shall follow the conformity assessment procedure based on internal control as referred to in Annex VI. 3. For high-risk AI systems covered by the Union harmonisation legislation listed in Annex I, the provider shall follow the relevant conformity assessment procedure as required under those legal acts.