EU Artificial Intelligence Act

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 Chapter 2 of this Title, 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.

Where, in demonstrating the compliance of a high-risk AI system with the requirements set out in Chapter 2 of this Title, the provider has not applied or has applied only in part harmonised standards referred to in Article 40, or where such harmonised standards do not exist and common specifications referred to in Article 41 are not available, the provider shall follow the conformity assessment procedure set out in Annex VII.

For the purpose of the conformity assessment procedure referred to in Annex VII, the provider may choose any of the notified bodies. However, when the system is intended to be put into service by law enforcement, immigration or asylum authorities as well as EU institutions, bodies or agencies, the market surveillance authority referred to in Article 63(5) or (6), as applicable, shall act as a notified body.

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, which does not provide for the involvement of a notified body. For high-risk AI systems referred to in point 5(b) of Annex III, placed on the market or put into service by credit institutions regulated by Directive 2013/36/EU, the conformity assessment shall be carried out as part of the procedure referred to in Articles 97 to101 of that Directive.

3.For high-risk AI systems, to which legal acts listed in Annex II, section A, apply, the provider shall follow the relevant conformity assessment as required under those legal acts. The requirements set out in Chapter 2 of this Title shall apply to those high-risk AI systems and shall be part of that assessment. Points 4.3., 4.4., 4.5. and the fifth paragraph of point 4.6 of Annex VII shall also apply.

For the purpose of that assessment, notified bodies which have been notified under those legal acts shall be entitled to control the conformity of the high-risk AI systems with the requirements set out in Chapter 2 of this Title, provided that the compliance of those notified bodies with requirements laid down in Article 33(4), (9) and (10) has been assessed in the context of the notification procedure under those legal acts.

Where the legal acts listed in Annex II, section A, enable the manufacturer of the product to opt out from a third-party conformity assessment, provided that that manufacturer has applied all harmonised standards covering all the relevant requirements, that manufacturer may make use of that option only if he has also applied harmonised standards or, where applicable, common specifications referred to in Article 41, covering the requirements set out in Chapter 2 of this Title.

4.High-risk AI systems shall undergo a new conformity assessment procedure whenever they are substantially modified, regardless of whether the modified system is intended to be further distributed or continues to be used by the current user.

For high-risk AI systems that continue to learn after being placed on the market or put into service, changes to the high-risk AI system and its performance that have been pre-determined by the provider at the moment of the initial conformity assessment and are part of the information contained in the technical documentation referred to in point 2(f) of Annex IV, shall not constitute a substantial modification.

5.The Commission is empowered to adopt delegated acts in accordance with Article 73 for the purpose of updating Annexes VI and Annex VII in order to introduce elements of the conformity assessment procedures that become necessary in light of technical progress.

6.The Commission is empowered to adopt delegated acts to amend paragraphs 1 and 2 in order to subject high-risk AI systems referred to in points 2 to 8 of Annex III to the conformity assessment procedure referred to in Annex VII or parts thereof. The Commission shall adopt such delegated acts taking into account the effectiveness of the conformity assessment procedure based on internal control referred to in Annex VI in preventing or minimizing the risks to health and safety and protection of fundamental rights posed by such systems as well as the availability of adequate capacities and resources among notified bodies.