Clinical Investigation

“A clinical investigation is defined as “any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety and/or performanceof a medical device.” The undertaking of a clinical investigation is a scientific process that represents one method of generating clinical data.
The objective of a clinical investigation is to assess the safety and clinical performance of the device in question and evaluate whether the device is suitable
for the purpose(s) and the population(s) for which it is intended (EN ISO 14155- 1:2009)”  (MEDDEV 2.7/4).