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Medical remedies
Matěvosova, Elena ; Rajchl, Jiří (advisor) ; Svoboda, Petr (referee)
Medical devices Abstract The subject of this master thesis is the issue of medical devices. This thesis focuses on its reimbursement regulation. The work is divided into six chapters. The introductory explanation is devoted to the concept of medical device and it analyzes both the European definition of medical device and the national legal definition. The next part of the chapter emphasizes various division of these products, namely its variants, types and also classification of medical devices according to risk classes. The second chapter describes legal sources. The attention is paid to international sources of law, then furthermore to European law, from current directives to new regulations, which will come into force in 2020. In this chapter is generally discussed what changes this new regulations bring, as it is further elaborated in the next chapter. Last but not least, the national sources of law are analyzed. The legal regulation enriched by the outline of the future legal regulation awaiting the area of medical devices is widely mentioned. The next chapter defines institutions. The Ministry of Health and the State Institute for Drug Control are the key institutions in the field of medical devices, however, they are not the only authorities to carry out state administration in the field of medical...
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