New finding

In clinical investigation and performance study safety reporting, new findings about an event already reported are sent as follow-up information. They can change the assessment of causality or seriousness.

New information discovered as the result of an inquiry/investigation/test based on the occurrence of the event. Follow-up from the event. See MDCG 2020-10/1.

MDCG 2024-4, Section 4.14

New information discovered as the result of an inquiry/investigation/test based on the occurrence of the event. Follow-up from the event.

MDCG 2020-10/1 Rev.1, Section 3.7