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Praxikon

Implementing act

Commission Implementing Decision (EU) 2026/2274 on the harmonised standards for high-risk AI systems

PublishedEuropean Commission14 Oct 2026

The decision of 12 October 2026 publishes the reference of EN 18286:2026 (Artificial intelligence, Quality management system for EU AI Act regulatory purposes) in the Official Journal of the EU. It appeared on 14 October 2026 and entered into force that day. EN 18286 is thereby the first harmonised standard under the AI Act: whoever applies the standard is presumed under Article 40 to meet the requirements the standard covers. The decision does not list those requirements article by article and attaches no restriction to the reference.

What this means for you

From 14 October 2026 a quality management system built to EN 18286 carries evidentiary weight. The presumption reaches only as far as the standard, so you still have to demonstrate the other high-risk requirements yourself.