AI Act, Article 43, SE

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 opt for one of the following conformity assessment procedures based on:

(a)

the internal control referred to in Annex VI; or

(b)

the assessment of the quality management system and the assessment of the technical documentation, with the involvement of a notified body, referred to in Annex VII.

In demonstrating the compliance of a high-risk AI system with the requirements set out in Section 2, the provider shall follow the conformity assessment procedure set out in Annex VII where:

(a)

harmonised standards referred to in Article 40 do not exist, and common specifications referred to in Article 41 are not available;

(b)

the provider has not applied, or has applied only part of, the harmonised standard;

(c)

the common specifications referred to in point (a) exist, but the provider has not applied them;

(d)

one or more of the harmonised standards referred to in point (a) has been published with a restriction, and only on the part of the standard that was restricted.

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