What is Clinical Evaluation and Investigation?
Clinical evaluation is an iterative, systematic, planned, documented and continuous process of data and information evaluation that allows the manufacturer, through its analysis and evaluation, to guarantee the clinical safety of the medical device. The clinical evaluati on will be exhaustive and objective, taking into account both favorable and unfavorable data. Its scope, depth and breadth will be proportional to the nature, classification, intended purpose and foreseeable risks of each product. The evaluation may be based on clinical data of products from which solid conclusions can be drawn due to their similarity and equivalence, as well as clinical investigations carried out in order to verify product conformity. In the analysis of equivalent products, the technical, biological and clinical characteristics of the products will be taken into account, to the extent that the differences do not imply clinical differences related to their safety and clinical functionin...