Article 8: Compliance with the requirements
provider · high risk · Article 8
High-risk AI systems must comply with the requirements of Chapter III Section 2, taking into account their intended purpose and the generally acknowledged state of the art. The risk management system under Article 9 is taken into account when ensuring compliance. Where a product is covered by both this Regulation and the Union harmonisation legislation in Annex I Section A, a single set of documentation may be produced.
How to satisfy it: The umbrella that binds Articles 9 to 15 together. Its practical value is the single- documentation rule: a product already carrying CE documentation under other Union harmonisation legislation does not maintain two parallel technical files.
Article 8 on EUR-Lex · as of 2026-08-03 · Regulation (EU) 2024/1689 as amended by Regulation (EU) 2026/1744