EU AI Act EUAI-Art.43: Conformity assessment

Providers must put each high-risk AI system through the correct conformity assessment procedure before it is placed on the market or put into service. For Annex III point 1 biometrics systems, where harmonised standards or common specifications have been applied, the provider chooses between internal control under Annex VI and assessment of the quality management system and the technical documentation with the involvement of a notified body under Annex VII; where such standards do not exist, were not applied, were applied only in part, or were published with a restriction, the Annex VII procedure must be followed. For Annex III points 2 to 8, internal control under Annex VI applies without notified body involvement. For systems covered by the Union harmonisation legislation in Section A of Annex I, the procedure required by that legislation applies and the Section 2 requirements form part of that assessment. A system already assessed must undergo a new conformity assessment on substantial modification; changes to a continuously learning system that were pre-determined by the provider at the initial assessment and recorded in the technical documentation are not a substantial modification.