Anticipated serious adverse device effect (ASADE)

Whether a serious effect was anticipated changes how it is handled in a clinical study, because unanticipated ones call for faster action and reporting. A risk assessment that is vague about expected effects makes this decision harder for investigators and sponsors.

Any serious adverse device effect which by its nature, incidence, severity or outcome has been identified in the risk assessment. See ISO 20916 section 3.5.

MDCG 2024-4, Section 4.3

Any serious adverse device effect which by its nature, incidence, severity or outcome has been identified in the last risk assessment document upon serious adverse device effect occurred.

MDCG 2020-10/1 Rev.1, Section 3.4

MDCG 2024-4 refers to the risk assessment in general and to ISO 20916, for performance studies. MDCG 2020-10/1 refers to the last risk assessment document available when the serious adverse device effect occurred.