The process of showing that a product meets the legal requirements that apply to it before it can be sold. In the European Union it is the step that entitles a product to carry the ‘CE’ marking, commonly read as Conformité Européenne. Under the European Union’s AI law, high-risk AI systems must go through one, either as a documented self-check by the maker or, in some cases, a review by an independent approved organisation.
Technical view
Under Article 43 of the AI Act, most Annex III high-risk systems use Annex VI internal control: the provider checks its quality management system and documentation. Biometric systems may need a notified body under Annex VII where harmonised standards are not fully applied, and AI in products such as medical devices follows the sectoral law’s procedure. Success brings a declaration of conformity, ‘CE’ marking (commonly read as Conformité Européenne) and registration; substantial modification triggers reassessment. Critics argue self-assessment gives providers too much latitude. The Digital Omnibus on AI deferred high-risk obligations to 2 December 2027 for Annex III systems and 2 August 2028 for sectorally regulated products.
Related
Part of AI Terminology Index, section: Governance, Law and Regulation.