EU AI Act Conformity Assessment and CE Marking

Conformity assessment is the process of demonstrating that a high-risk AI system meets the Act’s requirements. The provider is responsible for classifying, documenting and assessing the system before placing it on the market or putting it into service. The AI Act does not require CE marking for all AI tools; the duties discussed here attach to high-risk AI systems, which may also be subject to other EU product rules. For Annex III point 1, Article 43 allows internal control or notified-body assessment when relevant standards or common specifications are applied. Annex VII is required if neither standards exist nor common specifications are available; the standard is not applied or only partly applied; available specifications are not applied; or an applied standard has a restriction, only for that restricted part. Points 2–8 use Annex VI internal control. For Annex I products, Article 43(3) integrates Section 2 and Article 17 quality-management requirements into the sector procedure. A sectoral no-third-party option conditioned on standards covering all sector requirements is allowed only if standards or Article 41 common specifications also cover all Section 2 requirements. After assessment, the provider draws up an EU declaration of conformity, assumes responsibility for conformity, and affixes CE marking visibly and indelibly, or to packaging or documentation if the system’s nature makes that appropriate. Digitally provided systems may use a digital mark if readily accessible. A notified-body identification number accompanies the CE mark when applicable. The CE mark signals conformity with applicable requirements; it is not a quality award or general guarantee. Substantial modifications can trigger a new assessment, while predetermined changes documented in the original assessment are treated differently.