The clinical evaluation plays a key role during the development process of medical devices and for their market introduction. It is an essential element of the technical documentation and legally embodied in the Medical Devices Act. With the clinical evaluation, the safety and performance is to be proven on the basis of clinical investigation of the device concerned (or an equivalent device) or from published and/or unpublished reports on other clinical experience of the device concerned (or an equivalent device). Moreover, results of clinical studies related to an equivalent device, reported in the scientific literature can be used.”>clinical data. These may be obtained from different sources. If available clinical data derived from literature or experience databases are not sufficient to provide evidence of clinical safety and performance of your device, a clinical investigation is required.
The clinical evaluation is required for each medical device regardless of its classification. Thereby, the MEDDEV 2.7.1 guideline is a helpful orientation with regard to the methodological approach as well as the documentation of the content. The clinical evaluation is a continuous process and needs to be kept up-to-date over the entire product life cycle.
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