The clinical evaluation is required for each medical device regardless of its classification.
The clinical evaluation plays a major role when it comes to development and market introduction of medical devices. It is key element of the technical documentation and legally embodied in the German Medical Devices Act.
§19, section 1 of the medical product law and appendix X of the EU guidelines 93/42/EWG require that the suitability of all medical products be proven with respect to their designated use based on clinical data.
Clinical data are either derived from literature or experience databases or have to be generated by a clinical investigation. The clinical evaluation is required for each medical device regardless of its classification.
The clinical evaluation is a continuous process and needs to be kept up-to-date over the entire product life cycle.