Article 8: compliance with the requirements for high-risk AI systems

Paragraph 1 provides that 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. Paragraph 2 provides that, 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.

Read Article 8 not as an eighth requirement alongside the seven of Articles 9 to 15, but as the provision that says how those seven are to be read. It does two things none of the seven does itself. The first is that it brings in a measure from outside the Regulation. Article 8 is the only article in Section 2 that names the generally acknowledged state of the art, and that means the bar moves. A file that sufficed at the first conformity assessment does not necessarily still suffice some years later, without a single word of the Regulation changing: what was the state of the art then is no longer the state of the art later. The Regulation provides no re-certification rhythm for this beyond the substantial modification of Article 43(4), so anyone who does not set a rhythm of their own has none. Note also what the measure is not. The state of the art is not a synonym for a harmonised standard: Article 40 gives a presumption of conformity to whoever applies such a standard, but Article 8 sets an open measure alongside it that does not stop applying once the standard has been ticked off. The second is that paragraph 1 designates the risk management system of Article 9 as the instrument through which compliance with the other requirements is assessed. Article 9 is therefore not one requirement beside the other six but the file in which you show that you have met the other six at the right level. An organisation that keeps its risk analysis as a separate document beside the technical documentation misses exactly that connection.

Paragraph 2 is the anti-duplication provision, and in practice it is rarely used. It concerns the product that contains an AI system and falls both under this Regulation and under the Union harmonisation legislation of Section A of Annex I: that is precisely the route of Article 6(1). Two different things are stated. The first is an allocation: the provider is responsible for his product being fully compliant with everything the sectoral legislation requires. It does not say that the AI Act replaces or lightens the sectoral requirements, nor that the sectoral assessment swallows the requirements of Section 2; it says that both stacks apply at once and that the provider of the product covers both. The second is a choice, not a duty: he may integrate the testing and reporting processes, the information and the documentation on the product into the documentation and procedures the sectoral legislation already prescribes. We see two mistakes there. The first is that the AI Act file is built beside the existing technical file, with two versions of the same risk analysis that drift apart after two releases; that is exactly the duplication paragraph 2 seeks to avoid. The second is that the integration happens but cannot be found. Whoever enters the sectoral conformity assessment of Article 43(3) must be able to point, per requirement of Articles 9 to 15, to where in the existing file the answer sits. Integrating is therefore not merging into invisibility; it is a cross-reference per requirement, and that is the form in which the choice of paragraph 2 actually saves work.