Article 8 — Compliance with Requirements

Article 8

Compliance with the requirements

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.

ELI: http://data.europa.eu/eli/reg/2024/1689/oj 55/144
EN OJ L, 12.7.2024

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.