Adverse event (AE)

The definition does not require any link to the device, so events are recorded even when they seem unrelated. Deciding later whether the device played a role turns an adverse event into an adverse device effect. In the field after market launch, the vigilance terms incident and serious incident apply instead.

‘adverse event’ means any untoward medical occurrence, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a clinical investigation, whether or not related to the investigational device;

EU MDR, Article 2(57)

‘adverse event’ means any untoward medical occurrence, inappropriate patient management decision, unintended disease or injury or any untoward clinical signs, including an abnormal laboratory finding, in subjects, users or other persons, in the context of a performance study, whether or not related to the device for performance study;

IVDR, Article 2(60)

untoward medical occurrence, unintended disease or injury, or untoward clinical signs (including abnormal laboratory findings) in subjects (3.50), users or other persons, whether or not related to the investigational medical device (3.29) and whether anticipated or unanticipated Note 1 to entry: This definition includes events related to the investigational medical device or the comparator (3.12). Note 2 to entry: This definition includes events related to the procedures involved. Note 3 to entry: For users or other persons, this definition is restricted to events related to the use of investigational medical devices or comparators.

ISO 14155:2020, clause 3.2

The IVDR definition adds an inappropriate patient management decision and applies in the context of a performance study, while the MDR definition applies to a clinical investigation.