Medical devices: Regulation, risk classification, and open innovation

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/61989100:27240/20:10245316

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

Medical devices: Regulation, risk classification, and open innovation

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

Medical devices: Regulation, risk classification, and open innovation

Popis výsledku anglicky

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.

Druh

J_SC - Článek v periodiku v databázi SCOPUS

CEP obor

—

OECD FORD obor

50202 - Applied Economics, Econometrics

Projekt

<a href="/cs/project/GA17-03037S" target="_blank" >GA17-03037S: Hodnocení investic do vývoje zdravotních prostředků</a><br>

Návaznosti

P - Projekt vyzkumu a vyvoje financovany z verejnych zdroju (s odkazem do CEP)

Rok uplatnění

2020

Kód důvěrnosti údajů

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

Název periodika

Journal of Open Innovation: Technology, Market, and Complexity

ISSN

2199-8531

e-ISSN

—

Svazek periodika

6

Číslo periodika v rámci svazku

2

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

13

Strana od-do

"Article number 42"

Kód UT WoS článku

—

EID výsledku v databázi Scopus

2-s2.0-85089023592