Artificial intelligence: publication of the first harmonized standard developed in support of the European AI Act
By an implementing decision dated October 12, 2026, the European Commission published the first harmonized standard relating to high-risk AI systems, developed in support of Regulation (EU) 2024/1689 on artificial intelligence (“AI Act”)1 and covering the “Quality management system for EU AI Act regulatory purposes” (standard EN 18286:2026) (“Harmonized Standard”)2.
As a reminder, by reference to Regulation (EU) No. 1025/2012, the AI Act defines a harmonized standard as “a European standard adopted on the basis of a request made by the Commission for the application of Union harmonisation legislation.”3
Art. 40 of the AI Act further provides that “high-risk AI systems […] which are in conformity with harmonised standards or parts thereof the references of which have been published in the Official Journal of the European Union […]”4 are presumed to comply with the requirements applicable to high-risk AI systems set forth in Section 2 of Chapter III of the AI Act.
High-risk AI systems: a harmonized standard for quality management
In this case, the Harmonized Standard (developed by the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) in accordance with a request from the European Commission) is intended to help providers of high-risk AI systems comply with the quality management system requirements set forth in Art. 17 of the AI Act. Indeed, this article provides, in particular, that “Providers of high-risk AI systems shall put a quality management system in place that ensures compliance with this Regulation,” which must be “[…] documented in a systematic and orderly manner in the form of written policies, procedures and instructions […]”5 and must include certain aspects detailed by the AI Act, such as a strategy for regulatory compliance or techniques, procedures and systematic actions to be used for the design of high-risk AI systems.
As the Commission notes, harmonized standards aim to provide legal certainty within the framework of the AI Act, support innovation, and enable the European Union to set global benchmarks for trustworthy AI. Their application is voluntary, and AI system providers may choose other frameworks to demonstrate their compliance with the AI Act.6
In accordance with the European Commission’s requests, CEN and CENELEC are tasked with developing harmonized standards in other key areas such as risk management, governance and data set quality, transparency, and human oversight.
1 Regulation (EU) 2024/1689 of the European Parliament and of the Council of June 13, 2024
2 Implementing Decision (EU) 2026/2274 of October 12, 2026
3 Regulation (EU) 1025/2012 of the European Parliament and of the Council of October 25, 2012