The results of the clinical evaluation, as well as the clinical tests and evidence on which they are based, will be documented in a clinical evaluation report, which will serve as support and maximum evidence for the evaluation of the conformity of the product.

CLINICAL AND PRECLINICAL DATA

Clinical tests, together with non-clinical data generated by non-clinical test methods and other relevant documentation, will allow the manufacturer to demonstrate compliance with the general safety and performance requirements and will form an essential part of the product's technical documentation.

Both the favorable data and the unfavorable data that have been taken into account in the Clinical Evaluation Consultants must be included in the technical documentation.

The analysis of the preclinical data, especially the state of the art itself, will be used to put the scope of the clinical evaluation in context. This information will have been analyzed to determine a first risk acceptability policy, which must, in turn, be confirmed iteratively, in terms of residual risk acceptability.

This last acceptability incorporates the perception of the benefit/risk ratio of the product, where the outputs of the clinical evaluation and the information collected in each of the subsequent phases are taken into account.

THE MEDICAL DEVICE CLINIC IS THE SYSTEMATIC AND PLANNED PROCESS TO CONTINUOUSLY GENERATE, COLLECT, ANALYZE AND EVALUATE THE CLINICAL DATA OF A DEVICE TO VERIFY ITS SAFETY AND PERFORMANCE, INCLUDING CLINICAL BENEFITS, WHEN USED IN ACCORDANCE WITH THE DEFINED INTENDED PURPOSE. BY THE MANUFACTURER.