The Launching of Medical Devices - the Conformity Assessment and Registration Process in the Czech Republic

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F19%3A50015724" target="_blank" >RIV/62690094:18450/19:50015724 - isvavai.cz</a>
Alternative codes found
RIV/00179906:_____/19:10401892
Result on the web
<a href="https://uni.uhk.cz/hed/site/assets/files/1073/proceedings_2019_2-1.pdf" target="_blank" >https://uni.uhk.cz/hed/site/assets/files/1073/proceedings_2019_2-1.pdf</a>
DOI - Digital Object Identifier
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Result language
angličtina
Original language name
The Launching of Medical Devices - the Conformity Assessment and Registration Process in the Czech Republic
Original language description
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.
Czech name
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Czech description
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Project
<a href="/en/project/GA17-03037S" target="_blank" >GA17-03037S: Investment evaluation of medical device development</a><br>
Continuities
P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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