Many people colloquially refer to “clinical trials” as the source for clinical data for efficacy of treatments, where the trial is the activity of testing a medical device with patients to confirm that it provides clinical benefits.

In reality, this is what is defined as a clinical investigation within the regulations. The regulations also define a clinical evaluation as a wider scope activity, taking into account all scientific data as well as the data from a clinical investigation as a subset activity.


نظر دهید