IMPACTS OF THE SCHEDULED LEGISLATION CHANGE IN EUROPE FOR MEDICAL DEVICE PRODUCERS - SYSTEM DYNAMICS MODEL OF A FIRM

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F21%3A50018203" target="_blank" >RIV/62690094:18450/21:50018203 - isvavai.cz</a>
Result on the web
<a href="https://eds.p.ebscohost.com/abstract?site=eds&scope=site&jrnl=16484460&AN=153885459&h=6HyLuLiGwVEOIJzsIoCinkO3tEbp1lVZcwBWkD05Ep0xEn9tyI0GUNSpktgZLTUTnv3bjwbvUrWsvwsQkRJoDQ%3d%3d&crl=c&resultLocal=ErrCrlNoResults&resultNs=Ehost&crlhashurl=login.aspx%3fdirect%3dtrue%26profile%3dehost%26scope%3dsite%26authtype%3dcrawler%26jrnl%3d16484460%26AN%3d153885459" target="_blank" >https://eds.p.ebscohost.com/abstract?site=eds&scope=site&jrnl=16484460&AN=153885459&h=6HyLuLiGwVEOIJzsIoCinkO3tEbp1lVZcwBWkD05Ep0xEn9tyI0GUNSpktgZLTUTnv3bjwbvUrWsvwsQkRJoDQ%3d%3d&crl=c&resultLocal=ErrCrlNoResults&resultNs=Ehost&crlhashurl=login.aspx%3fdirect%3dtrue%26profile%3dehost%26scope%3dsite%26authtype%3dcrawler%26jrnl%3d16484460%26AN%3d153885459</a>
DOI - Digital Object Identifier
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Result language
angličtina
Original language name
IMPACTS OF THE SCHEDULED LEGISLATION CHANGE IN EUROPE FOR MEDICAL DEVICE PRODUCERS - SYSTEM DYNAMICS MODEL OF A FIRM
Original language description
In 2021, Europe will face a fundamental change in medical device (MD) legislation with the introduction of obligatory clinical trials in lower-risk classes post-entry to the market. This change raises questions for future economic results of MD companies. We present a system dynamics (SD) model of a small company based on explicit representation of a new MD development, emphasizing the importance of the imposed legislation on otherwise intuitive management decision making. The model projections show that for small companies, the new legislation would result in almost doubling certification costs. Though the implementation of the MDR 2017/745 directive aims to increase patient safety, in the context of market development, such measures may lead to increased pressure on the horizontal integration of companies, with the exit of small firms from the market and the related decline in R&D activities at the SME level.
Czech name
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Czech description
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Type
J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database
CEP classification
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OECD FORD branch
50204 - Business and management

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
2021
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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