Medical devices: Regulation, risk classification, and open innovation

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F20%3A50017038" target="_blank" >RIV/62690094:18450/20:50017038 - isvavai.cz</a>

Alternative codes found

RIV/61989100:27240/20:10245316

Result on the web

<a href="https://www.mdpi.com/2199-8531/6/2/42" target="_blank" >https://www.mdpi.com/2199-8531/6/2/42</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/JOITMC6020042" target="_blank" >10.3390/JOITMC6020042</a>

Result language

angličtina

Original language name

Medical devices: Regulation, risk classification, and open innovation

Original language description

In the Czech Republic, the medical device industry is an important sector with a strong tradition and has high added value and perspectives in demand under changing demographic and social structures. The aim of this article is to describe and analyze the complex issues of the new European Commission Medical Device Regulation (MDR) 2017/745 from the perspective of the strategic decisions of companies that have to comply with the requirements imposed on them by the new legislation and at the same time fulfill their own business needs and goals. The legislative changes significantly affect the standards, processes, and certifications in the medical device sector. The classification system of medical devices has been revised to more appropriately reflect the possible health risks associated with use of modern high-end technology in healthcare. The requirement is to categorize each device under the highest possible risk class, which means for the medical device manufacturers to carefully review the new rules and regulations and classify their devices accordingly. © 2020 by the authors.

Czech name

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Czech description

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Type

J_SC - Article in a specialist periodical, which is included in the SCOPUS database

CEP classification

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OECD FORD branch

50202 - Applied Economics, Econometrics

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

2020

Confidentiality

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

Name of the periodical

Journal of Open Innovation: Technology, Market, and Complexity

ISSN

2199-8531

e-ISSN

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Volume of the periodical

6

Issue of the periodical within the volume

2

Country of publishing house

CH - SWITZERLAND

Number of pages

13

Pages from-to

"Article number 42"

UT code for WoS article

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EID of the result in the Scopus database

2-s2.0-85089023592