Adverse device effect (ADE)

Every adverse device effect is an adverse event, but not every adverse event is a device effect. The link to the device is what moves it into this category, so the causality assessment by the investigator and sponsor is the step that decides how it is recorded and reported.

adverse event (3.2) related to the use of an investigational medical device (3.34) Note 1 to entry: This definition includes adverse events resulting from insufficient or inadequate instructions for use, deployment, implantation, installation, or operation, or any malfunction (3.33) of the investigational medical device. Note 2 to entry: This definition includes any event resulting from use error (3.53) or from intentional misuse of the investigational medical device. Note 3 to entry: This includes “comparator” (3.12) if the comparator is a medical device.

ISO 14155:2020, clause 3.1

An adverse device effect is any adverse event related to the use of an investigational medical device or a comparator if the comparator is a medical device.

MDCG 2024-3, Abbreviations, footnote 1

Any adverse event related to the use of a device for performance study or a comparator. See ISO 20916 section 3.1.

MDCG 2024-4, Section 4.1

Any adverse event related to the use of an investigational medical device or a comparator.

MDCG 2020-10/1 Rev.1, Section 3.3

MDCG 2020-10/1 and MDCG 2024-3 refer to an investigational medical device, and MDCG 2024-3 counts the comparator only when the comparator is a medical device. MDCG 2024-4 applies the term to a device for performance study under the IVDR and refers to ISO 20916.