AI Act: first harmonised standard cited in the Official Journal, EN 18286

Commission Implementing Decision (EU) 2026/2274 of 12 October 2026, published in the Official Journal on 14 October, cites EN 18286 on the quality management system for high-risk AI systems. It is the first harmonised standard under the AI Act. Providers applying it benefit from a presumption of conformity for the requirements it covers (Article 17, quality management system, including post-market monitoring).

What it means: it mainly targets providers of high-risk AI systems. ISO/IEC 42001 is not a harmonised standard and does not give this presumption, but it remains a strong base. With the AI Omnibus, high-risk obligations apply on 2 December 2027 (Annex III) and 2 August 2028 (Annex I): about a year to build the quality system.

Source: Implementing Decision (EU) 2026/2274, EUR-Lex. Read on the Cyberbits regulatory watch · Book a free 30-minute call