The launching of medical devices - the conformity assessment and registration process in the Czech republic
The result's identifiers
Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F00179906%3A_____%2F19%3A10401892" target="_blank" >RIV/00179906:_____/19:10401892 - isvavai.cz</a>
Alternative codes found
RIV/62690094:18450/19:50015724
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
<a href="http://dx.doi.org/10.36689/uhk/hed/2019-02-000" target="_blank" >10.36689/uhk/hed/2019-02-000</a>
Alternative languages
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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Classification
Type
D - Article in proceedings
CEP classification
—
OECD FORD branch
50501 - Law
Result continuities
Project
<a href="/en/project/GA17-03037S" target="_blank" >GA17-03037S: Investment evaluation of medical device development</a><br>
Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace
Others
Publication year
2019
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů
Data specific for result type
Article name in the collection
Hradec Economic Days. Vol. 9(2)
ISBN
978-80-7435-736-7
ISSN
2464-6059
e-ISSN
2464-6067
Number of pages
8
Pages from-to
126-133
Publisher name
Univerzita Hradec Králová, Fakulta informatiky a managementu
Place of publication
Hradec Králové
Event location
Hradec Kralove
Event date
Feb 5, 2019
Type of event by nationality
EUR - Evropská akce
UT code for WoS article
000462181100012