Article 43High-risk
Conformity assessment
Provider
Deadline: August 2, 2026
Article 43 defines the conformity assessment procedures that providers must follow before placing on the market or putting into service a high-risk AI system. The procedure varies by system type and may include self-assessment or intervention by a notified body.
Key points
1Self-assessment based on internal control for most systems (Annex VI)
2Assessment by notified body for certain biometric identification systems
3New assessment required in case of substantial modification
4Documentation of procedure followed and results obtained
5Compliance with harmonized standards offers presumption of conformity
Related definitions
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