What is a clinical evaluation, and how does it take place?
The clinical evaluation is the document that collects and analyzes the set of clinical data on the medical device or equivalent devices and all information on state of the art in the specific sector in which the medical device is used. It aims to evaluate the benefit/risk profile from the clinical point of view of using the medical device and is therefore related to the risk analysis, just as it aims to demonstrate the fulfillment of the relevant essential requirements. The clinical evaluation starts with developing a previously planned process and is carried out in the drafting of a report document. It must be updated periodically or as soon as it becomes aware of information that may affect the conclusions of the assessment itself; collects the info coming from supervisory and surveillance activities; critically analyzes the relevant medical-scientific literature and must evaluate, when present, the clinical investigations carried out with the medical device. The clinical e