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Article 8

Compliance with the Requirements

Updated on May 8th 2024 based on the version and article numbering in the EU Parliament's 'Corrigendum' version dated April 19th 2024.

1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purpose as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.

2. Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplication and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I.

[Previous version]

Updated on April 10th 2024 based on the version and article numbering approved by the EU Parliament on March 13th 2024.

1. High-risk AI systems shall comply with the requirements laid down in this Section, taking into account their intended purposes as well as the generally acknowledged state of the art on AI and AI-related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.

2. Where a product contains an AI system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Section A of Annex I apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements required under applicable Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred to in paragraph 1 with the requirements set out in this Section, and in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice of integrating, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into documentation and procedures that already exist and are required under the Union harmonisation legislation listed in Section A of Annex I,.

Updated on Feb 6th 2024 based on the version endorsed by the Coreper I on Feb 2nd

1. High-risk AI systems shall comply with the requirements established in this Chapter, taking into account its intended purpose as well as the generally acknowledged state of the art on AI and AI related technologies. The risk management system referred to in Article 9 shall be taken into account when ensuring compliance with those requirements.

2a. Where a product contains an artificial intelligence system, to which the requirements of this Regulation as well as requirements of the Union harmonisation legislation listed in Annex II, Section A apply, providers shall be responsible for ensuring that their product is fully compliant with all applicable requirements required under the Union harmonisation legislation. In ensuring the compliance of high-risk AI systems referred in paragraph 1 with the requirements set out in Chapter 2 of this Title, and in order to ensure consistency, avoid duplications and minimise additional burdens, providers shall have a choice to integrate, as appropriate, the necessary testing and reporting processes, information and documentation they provide with regard to their product into already existing documentation and procedures required under the Union harmonisation legislation listed in Annex II, Section A.

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