Article 8: Compliance with the requirements

Paragraph 1 states the master rule: high-risk AI systems must meet all Section 2 requirements (Articles 9–15 and related annexes) with intended purpose and state of the art in view, and must embed the Article 9 risk management system in that compliance story.

Paragraph 2 addresses combined product + AI Act situations: if Union harmonisation legislation listed in Annex I Section A also applies, the provider must ensure the product satisfies both sets of rules. The second subparagraph encourages integration of testing, reporting, information, and documentation into existing conformity procedures under that harmonisation law to avoid duplication—read the exact conditions on EUR-Lex.

Use Article 8 as the table of contents for your evidence map, then drill into Articles 9–15.

• Article 6 — When Section 2 applies.
• Article 9 through Article 15 — Substantive Section 2 requirements Article 8 summarises.
• Annex I — Section A product laws referenced in Article 8(2).
• Annex IV — Technical documentation is a core evidence pillar alongside Section 2.
• Articles 16–27 — Obligations of providers, deployers, importers, distributors once high-risk duties bite.
• Article 43 — Conformity assessment routes interact with how you prove Section 2 compliance.
• Article 113 — Dates when many high-risk rules become operational.

• Build a matrix: each Article 9–15 requirement → owner → artefact → review cadence.
• For embedded products, assign a single responsible compliance lead who owns both AI Act and sectoral files (Article 8(2)).
• Map state of the art claims to public standards, peer-reviewed methods, and internal benchmarks; refresh at major releases.
• Where sectoral NB (notified body) processes exist, design shared evidence packs permitted under Article 8(2) second subparagraph—verify wording on EUR-Lex.
• Link risk management outputs directly to test protocols and release gates.

Editorial note: The following reproduces Article 8(1) and (2) from the English consolidated text of Regulation (EU) 2024/1689. If the OJ layout differs, EUR-Lex Article 8 prevails.

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.

The recitals in the same consolidated AI Act on EUR-Lex explain proportionality, alignment with product law, and state of the art expectations that underpin Article 8. Use the official preamble on EUR-Lex—do not rely on unofficial recital lists without checking sequence and wording against the authentic text.