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Recital 58

Definition of 'serious incident'

Regulation (EU) 2024/1689 - Artificial Intelligence Act · Preamble

As regards safety, the notion of a 'serious incident' under this Regulation should cover incidents that result in death or serious damage to health, serious and irreversible disruption of the management or operation of critical infrastructure, infringements of obligations under Union law intended to protect fundamental rights, or serious damage to property or the environment. For high-risk AI systems, this notion should also be relevant for post-market monitoring and for reporting obligations. The notion should be understood taking into account sector-specific approaches, established concepts and practices in specific domains such as product safety, aviation safety, healthcare, or other fields with established incident reporting procedures. It is essential for the proper functioning of the post-market monitoring system to ensure that all relevant serious incidents are identified and analysed to identify any potential for systemic risks.