‘Serious adverse event’ means 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. EU 536/2014 Art. 2 Abs. 2 (33)

‘Serious adverse event’ means 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 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,

(c) foetal distress, foetal death or a congenital physical or mental impairment or birth defect. MDR Art. 2 (58)