Skip to Main Content

[標題]最新消息

EU publishes a harmonised standard for high-risk AI systems supporting the AI Act

On 14 October 2026, the European Commission published Implementing Decision (EU) 2026/2274. It lists EN 18286:2026 as a harmonised standard developed to support the Artificial Intelligence Act (Regulation (EU) 2024/1689).

The standard was developed by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC), following a request from the Commission. The decision says the standard covers quality management systems for providers of AI systems, including post-market monitoring. After assessing the standard, the Commission, CEN and CENELEC found that EN 18286:2026 meets the AI Act requirements it is intended to cover. The Commission therefore published its reference in the Official Journal of the European Union.

Under Article 40 of the AI Act, compliance with a harmonised standard whose reference has been published in the Official Journal gives a presumption of conformity with the legal requirements covered by that standard.

Additional note: This presumption applies only to the requirements covered by the standard. In practice, companies may also need to check how other applicable obligations relate to their systems. This is a practical reminder based on the relevant legislation; it is not stated in the implementing decision itself.

Links:
Commission Implementing Decision (EU) 2026/2274 (opens in a new window)
Article 40 of the EU Artificial Intelligence Act (opens in a new window)