Preklinické a klinické hodnocení zdravotnického prostředku

Abstract

This bachelor thesis focuses on the preclinical and clinical evaluation of medical devices from the point of view not only of newly prepared legislation, but also from the point of view of existing legislation and comparable standards valid in the United States of America. For the reason, that the new European legislation MDR 2017/745 valid in the Member States of the European Union was approved in 2017, the aim of this work is to describe, compare existing legislation with this new regulation, create a preclinical and clinical evaluation of a particular device. A preclinical and clinical evaluation of a particular medical device has been performed and incorporated into the conformity assessment process. The changes, differences in preclinical and clinical evaluation of medical devices in Europe between the standards that are still in force and the new regulation. The positive impact of these changes persists, in particular, for consumers because of the increased safety and traceability of products. From the point of view of manufacturers, there are rather risks in the form of high financial costs of reclassification of funds and subsequent conformity assessment by the notified person.