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COMPEL Glossary / serious-incident-art-3-49

Serious incident (Art. 3(49))

Under Regulation (EU) 2024/1689, an incident or malfunction of an AI system that directly or indirectly leads to the death of a person or serious harm to a person's health, to a serious and irreversible disruption of critical infrastructure, to infringement of fundamental-rights obligations, or to serious harm to property or the environment.

Synonyms

EU AI Act serious incident , Article 3(49) serious incident

See also

  • High-risk AI system — Under Regulation (EU) 2024/1689, an AI system falling under Article 6(1) because it is a safety component of, or is itself, a product covered by Annex I Union harmonization legislation, or under Article 6(2) because its use case falls within Annex III — unless exempted by the Article 6(3) derogation..
  • Post-market monitoring (Art. 72) — Under Regulation (EU) 2024/1689, the ongoing, documented collection, analysis, and corrective-action process that providers of high-risk AI systems must operate after the system is placed on the market.
  • AI incident (for LLMs) — A subtype of the NIST AI RMF MANAGE 1.4 incident concept specific to LLM systems: confident-but-wrong answer, safety bypass, prompt injection success, sensitive data leakage, or policy-violating tool-call execution.
  • National competent authority — Under Regulation (EU) 2024/1689, the authority designated by each Member State — covering market-surveillance and notifying-authority functions — responsible for enforcement of the Act at national level, including serious-incident handling, audit, and sanction decisions..