Adverse Event (AE)
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. (MDR Article 2(57))
Note:
a. This definition includes events that are anticipated as well as unanticipated events
b. This definition includes events occurring in the context of a clinical investigation related to the investigational device, the comparator or the procedures involved.
[Definition of the term according to MDCG 2020-10/1]