Article 43 · Chapter III: High-Risk AI Systems
Conformity Assessment
High risk
Summary
Sets the routes to conformity assessment for high-risk AI systems. For most Annex III systems where harmonised standards apply: internal control (Annex VI). For biometric systems and where standards are not (fully) applied: notified-body assessment (Annex VII). For Annex I product-safety systems: the conformity assessment procedures of the underlying sectoral law, augmented by AI Act requirements.
Key obligations
- Choose the right conformity assessment route per Annex III/I context
- Re-assess on substantial modifications
- Notified-body involvement is mandatory for some categories