The launching of medical devices - the conformity assessment and registration process in the Czech republic
Abstrakt
The issue of launching medical devices is very topical. This is an area that is little described because more attention is paid to medicinal products.
This paper aims to comprehensively describe and analyze the theoretical background of current legislation regulating the marketing of medical devices, including other processes related to this issue. The article discusses the concept of medical device, the manufacturer's responsibility and the nature of the notified body.
In addition, it describes processes of conformity assessment and registration. Finally, the findings of regulation of medical devices are summarized.
Emphasis is placed on the position of the manufacturer as a primary person and the criticism of the absence of a proper legal theoretical examination of all the problems mentioned.