High-Risk AI Conformity Assessment

Select, complete and document the conformity-assessment procedure applicable to each high-risk AI system, including reassessment after substantial modification.

For the responsible high-risk AI provider, document the applicable conformity-assessment route before release. Check the classification, product legislation and relevant standards or common specifications. Distinguish Annex III routes from Annex I Section A product procedures; a notified body is not required for every high-risk system. Assemble the applicable technical and quality evidence, resolve findings and retain the assessment decision. Reassess substantial modifications and review certificate continuity if a notified body's status changes. A product manufacturer treated as the provider follows the relevant provider route. The manufacturer's responsibility and the notified body's assessment role remain distinct.

Before applicable market placement or putting into service; on substantial modification; on relevant certificate or notified-body changes.

Classification and conformity-route decision Applicable standards or common-specification analysis Technical and quality evidence package Assessment findings, certificates and closure records where relevant Substantial-modification and certificate-continuity decisions

Select a released or modified system and reconcile the chosen route to its classification and product legislation. Check completion of the applicable assessment, closure of findings and any certificate validity or transfer conditions.