Under the EU AI Act, an incident or malfunction of a high-risk AI system that directly or indirectly causes death, serious damage to health or property, or serious and irreversible disruption of critical infrastructure. Serious incidents trigger mandatory reporting to market surveillance authorities. Incident classification and reporting procedures should be integrated into the provider's QMS.
See: EU AI Act; High-risk AI system; Incident response; Post-market monitoring; Provider; Quality Management System