AI Act implementing decision: harmonised standard EN 18286 on quality management systems for high-risk AI
This implementing decision publishes in the OJ the reference of the first AI Act harmonised standard, EN 18286:2026 'Artificial intelligence - Quality management system for EU AI Act regulatory purposes'. Developed by CEN and CENELEC under standardisation request C(2025) 3871, it covers quality management systems for AI system providers, including post-market monitoring processes. Under AI Act Article 40, conformity gives a presumption of conformity with the requirements it covers from the date of publication. Adopted 12 October 2026, published and in force on 14 October 2026.
Timeline
- 14 Oct 2026Reference of EN 18286:2026 published in the OJ; presumption of conformity from that date
- 2 Dec 2027Annex III high-risk AI system obligations apply (per Regulation (EU) 2026/1744)
- 2 Aug 2028Annex I high-risk AI system obligations apply (per Regulation (EU) 2026/1744)
Key facts
- Reference
- Commission Implementing Decision (EU) 2026/2274
- Adopted
- 12 Oct 2026
- Published
- 14 Oct 2026
- Status
- In force
- Amendments
- Harmonised standard published under Article 40 of Reg (EU) 2024/1689 (AI Act)
- Topic
- Cybersecurity & Data
- Industries
- Cross-sector, Electronics Manufacturing, Healthcare & Biotech, Automotive, Toy Manufacturing
Main compliance requirements
Paid members only
The main compliance requirements, applicability questions and penalties are available in the ZC Smart Compliance Hub. Paid members and clients can sign in to the Hub to view them.
Related legislation
- Under Article 40 of Regulation (EU) 2024/1689 (AI Act, as amended by Regulation (EU) 2026/1744). Related: standardisation request Implementing Decision C(2025) 3871, Regulation (EU) No 1025/2012 (European standardisation).
Official sources
Commission Implementing Decision (EU) 2026/2274 of 12 October 2026 on the harmonised standards for high-risk AI systems drafted in support of Regulation (EU) 2024/1689 of the European Parliament and of the Council
Full text on EUR-Lex (Commission Implementing Decision (EU) 2026/2274)