Harmonized standard

A European standard developed by CEN, CENELEC, or ETSI in response to a Commission standardization request and referenced in the Official Journal. Under Article 40, AI systems or GPAI models that comply with a harmonized standard (or relevant parts of it) are presumed to conform to the AI Act requirements covered by that standard. Harmonized standards are the primary mechanism for providers to establish conformity without going to a notified body for third-party conformity assessment. The first AI Act harmonized standards are in development (see prEN 18286) but none had been published in final form as of June 2026.

A technical standard adopted at EU level whose application can create a presumption of conformity with the corresponding legal requirements. As of 2026 the harmonized standards for the AI Act are still being finalized, so most files describe other solutions applied (for example international ISO/IEC standards) instead.

A technical standard, such as CEN-CENELEC's prEN 18286, that when adopted creates a presumption of conformity with the AI Act's requirements when followed; these standards are converging toward the same evidence-and-gap structure this topic's walkthrough method teaches. (see Topic 8.6)