serious incident
as defined in Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL LAYING…, Article 3, point (44) (Definitions)
any incident that directly or indirectly leads, might have led or might lead to any of the following: (a)the death of a person or serious damage to a person’s health, to property or the environment, (b)a serious and irreversible disruption of the management and operation of critical infrastructure.
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Also defined in
- Regulation (EU) 2025/327 of the European Parliament and of the Council of 11 February 2025 on the European Health Data… 32025R0327, Article 2(2), point (r)
any malfunction or deterioration in the characteristics or performance of an EHR system made available on the market that directly or indirectly leads, might have led or might lead to any of the following: (i) the death of a natural person or serious harm to a natural person’s health; (ii) serious… - AI Act 32024R1689, Article 3, point (49)
an incident or malfunctioning of an AI system that directly or indirectly leads to any of the following: (a) the death of a person, or serious harm to a person’s health; (b) a serious and irreversible disruption of the management or operation of critical infrastructure; (c) the infringement of… - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical… 32017R0746, Article 2, point (68)
any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending… 32017R0745, Article 2, point (65)
any incident that directly or indirectly led, might have led or might lead to any of the following: (a) the death of a patient, user or other person, (b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health, (c) a serious public health threat - Regulation (EU) No 376/2014 of the European Parliament and of the Council of 3 April 2014 on the reporting, analysis… 32014R0376, Article 2, point (4)
a serious incident within the meaning of Regulation (EU) No 996/2010 - Regulation (EU) No 996/2010 of the European Parliament and of the Council of 20 October 2010 on the investigation and… 32010R0996, Article 2, point (16)
an incident involving circumstances indicating that there was a high probability of an accident and is associated with the operation of an aircraft, which in the case of a manned aircraft, takes place between the time any person boards the aircraft with the intention of flight until such time as… - Council Directive 94/56/EC of 21 November 1994 establishing the fundamental principles governing the investigation of… 31994L0056, Article 3, point (k)
an incident involving circumstances indicating- that an accident nearly occurred (a list of examples of serious incidents can be found in the Annex);