The first harmonised standard for the AI Act has been published in the Official Journal: EN 18286 on quality management systems

By Implementing Decision (EU) 2026/2274 of 12 October 2026 the Commission published in the Official Journal the reference to the first harmonised standard for the AI Act, EN 18286:2026 ‘Artificial intelligence – Quality management system for EU AI Act regulatory purposes’. The decision was published on 14 October 2026 and entered into force on the same day.

The standard was drafted by CEN and CENELEC on the basis of the Commission's standardisation request of June 2025. Providers of high-risk AI systems that apply it benefit, under Article 40, from a presumption of conformity with the Article 17 requirements on the quality management system to the extent covered by the standard. According to the Commission, the standard is built around the AI system lifecycle and can be layered on top of existing management systems such as ISO/IEC 42001, ISO 9001 or sectoral standards (e.g. ISO 13485).

Further harmonised standards are to follow. Under the Digital Omnibus on AI, the requirements for high-risk systems apply from 2 December 2027 (areas listed in Annex III) and from 2 August 2028 (products under Annex I).