AI Act harmonis…

AI Act implementing decision: harmonised standard EN 18286 on quality management systems for high-risk AI

Commission Implementing Decision (EU) 2026/2274
In forceImplementing DecisionCybersecurity & Data

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

  1. 14 Oct 2026
    Reference of EN 18286:2026 published in the OJ; presumption of conformity from that date
  2. 2 Dec 2027
    Annex III high-risk AI system obligations apply (per Regulation (EU) 2026/1744)
  3. 2 Aug 2028
    Annex 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

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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)

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