Serious adverse event (SAE)

The outcome decides whether an event is serious, not how unexpected or how device-related it is. Sponsors report SAEs during clinical investigations and performance studies, which is a separate system from vigilance reporting of serious incidents once the device is on the market.

‘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;

EU MDR, Article 2(58)

‘serious adverse event’ means 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;

IVDR, Article 2(61)

adverse event (3.2) that led to any of the following: a) death. b) serious deterioration in the health of the subject (3.50), users, or other persons as defined by one or more of the following: a) a life-threatening illness or injury, or b) a permanent impairment of a body structure or a body function including chronic diseases, or c) in-patient or prolonged hospitalization, or d) medical or surgical intervention to prevent life-threatening illness or injury, or permanent impairment to a body structure or a body function; e) foetal distress, foetal death, a congenital abnormality, or birth defect including physical or mental impairment. Note 1 to entry: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP (3.9), without serious deterioration in health, is not considered a serious adverse event.

ISO 14155:2020, clause 3.45

The IVDR adds outcomes specific to diagnostics: a patient management decision based on the test that led to death or an imminent life-threatening situation for the person tested, or the death of their offspring. It also extends serious deterioration to recipients of tested donations or materials.