Serious Incident

An event involving an AI system that results in or materially contributes to death, bodily injury, significant economic loss, substantial impairment of fundamental rights, or other serious harms; such incidents trigger mandatory reporting within specified timeframes to enable regulatory response and market surveillance.

An incident related to the use of an AI system that has led or may lead to death, serious injury, a severe adverse effect on health or safety, serious damage to property, or a serious breach of fundamental rights; such incidents trigger reporting obligations, corrective actions and potential enforcement by competent authorities.

An adverse event related to the use of an AI system that results in death, serious physical or mental injury, significant damage to property, or a substantial impairment of fundamental rights; such incidents trigger mandatory reporting duties, remediation and cooperation with competent authorities under the Act.

An event involving an AI system that causes or could cause significant adverse effects to health, safety or fundamental rights, which triggers mandatory reporting, post‑market monitoring obligations and may lead to corrective measures, recalls or enforcement actions by competent authorities.