serious adverse event
as defined in Regulation (EU) 2017/746 of the European Parliament and of the Council of 5…, Article 2, point (61) (Definitions)
any adverse event that led to any of the following: (a) a patient management decision resulting in death or an imminent life-threatening situation for the individual being tested, or in the death of the individual's offspring, (b) death, (c) serious deterioration in the health of the individual being tested or the recipient of tested donations or materials, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or prolongation of patient hospitalisation, (iv) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function, (v) chronic disease, (d) foetal distress, foetal death or a congenital physical or mental impairment or birth defect
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Also defined in
- Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending… 32017R0745, Article 2, point (58)
any adverse event that led to any of the following: (a) death, (b) serious deterioration in the health of the subject, that resulted in any of the following: (i) life-threatening illness or injury, (ii) permanent impairment of a body structure or a body function, (iii) hospitalisation or… - Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on… 32014R0536, Article 2(2), point (33)
any untoward medical occurrence that at any dose requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, results in a congenital anomaly or birth defect, is life-threatening, or results in death - Directive 2004/23/EC of the European Parliament and of the Council of 31 March 2004 on setting standards of quality and… 32004L0023, Article 3, point (m)
any untoward occurrence associated with the procurement, testing, processing, storage and distribution of tissues and cells that might lead to the transmission of a communicable disease, to death or life-threatening, disabling or incapacitating conditions for patients or which might result in, or… - Directive 2002/98/EC of the European Parliament and of the Council of 27 January 2003 setting standards of quality and… 32002L0098, Article 3, point (g)
any untoward occurrence associated with the collection, testing, processing, storage and distribution, of blood and blood components that might lead to death or life-threatening, disabling or incapacitating conditions for patients or which results in, or prolongs, hospitalisation or morbidity