Serious adverse device effect (SADE)

SADEs are the serious adverse events where a link to the device or the procedure is established or possible. In EU clinical investigations they fall under the MDR safety reporting rules that MDCG 2020-10/1 explains.

adverse device effect (3.1) that has resulted in any of the consequences characteristic of a serious adverse event (3.45)

ISO 14155:2020, clause 3.44

Any adverse device effect that has resulted in any of the consequences characteristic of a SAE.

MDCG 2024-3, Abbreviations, footnote 3

Any adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event. An adverse device effect is any adverse event related to the use of an investigational device or a comparator, if the comparator is a medical device.

MDCG 2024-5, Abbreviations, footnote 3

Any ADE that has resulted in any of the consequences characteristic of a serious adverse event. See ISO 20916 section 3.43.

MDCG 2024-4, Section 4.17

Any adverse device effect that has resulted in any of the consequences characteristic of a serious adverse event.

MDCG 2020-10/1 Rev.1, Section 3.9