Conformity assessment for high-risk AI systems

Providers of high-risk AI systems listed in Annex III must follow specific conformity assessment procedures to demonstrate compliance with regulatory requirements. For systems in Annex III, point 1, providers can choose between internal control or a notified body assessment, depending on the availability of harmonised standards or common specifications. Providers of systems in Annex III, points 2 to 8, must use the internal control procedure without notified body involvement. Providers must undergo a new conformity assessment for substantial modifications, except for pre-determined learning changes documented in technical files. For systems covered by other EU harmonisation legislation, providers must follow the relevant assessment procedures while ensuring compliance with AI Act requirements.