Article 43: Conformity Assessment for High-Risk AI Systems
provider · high risk · Article 43
Article **43** determines **which conformity assessment procedure** a high-risk AI system must follow before it can be placed on the market or put into service. For **Annex III point 1** (biometric) systems where harmonised standards or common specifications have been applied, the provider may choose between **internal control** (Annex VI) or **notified body** assessment (Annex VII). Where harmonised standards do not exist, are not applied, or are published with restrictions, the **notified body** route (Annex VII) is mandatory for point 1 systems. For **Annex III points 2 to 8**, providers follow **internal control** (Annex VI) with no notified body involvement. For **Annex I** product-law systems, the existing sectoral conformity assessment procedure applies, integrating AI Act Section 2
How to satisfy it: Perform self-assessment or third-party assessment as per Annex V/VI/IX. Affix CE marking if compliant.
Article 43 on EUR-Lex · as of 2026-08-03 · Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744