Clinical data is the information about the safety and performance from the use of a medical device on human beings. For the CE marking of the medical device, it is necessary to demonstrate the clinical safety and performance by the analysis of this clinical data. The clinical evaluation is the systematic process of planning, collecting the clinical data, appraising and analyzing the same.
The clinical data generated with the clinical evidence is acquired through two routes. One is through the clinical investigations performed on human beings with the respective medical device. The other is the literature route in which the literature with the clinical evidence of the studies conducted on human beings with the equivalent devices is acquired. In the second case, we need to demonstrate the equivalence with the comparable medical device with our respective medical device.
Is it mandatory to perform the clinical evaluation for all medical devices for the CE marking? Is it possible to use both the clinical investigation and literature routes for the clinical evaluation of a medical device? How can we determine what are information on safety and performance as the clinical data?