New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F20%3A50016840" target="_blank" >RIV/62690094:18450/20:50016840 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.mdpi.com/2076-3387/10/1/16" target="_blank" >https://www.mdpi.com/2076-3387/10/1/16</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3390/admsci10010016" target="_blank" >10.3390/admsci10010016</a>

Jazyk výsledku

angličtina

Název v původním jazyce

New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?

Popis výsledku v původním jazyce

Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this paper is to analyze patent activity based on the example of the selected country (Czech Republic), compare it with selected foreign countries, and discuss the development of this industry in the context of new medical device regulation (MDR) implementation. The paper is based on the theoretical concept of the relationship between regulation and innovation. The main challenge in the implementation of the new medical device regulations lies in the area of innovation. This is because most innovative research in the medical device sector is undertaken by small to medium enterprises (SMEs) rather than by large companies. SMEs are more vulnerable than big companies when it comes to development because the accompanying administrative costs can be so high that it may force the company to leave the market. Given that the main reason for the existence of economic regulations are various forms of market failure, which occurs when market mechanisms do not lead to results that benefit society, any attempts to redress this situation should naturally lead to greater benefits for society and hence benefits for the given industry as well.

Název v anglickém jazyce

New Regulations on Medical Devices in Europe: Are They an Opportunity for Growth?

Popis výsledku anglicky

Increasing demand for modern treatments and significant profit margins are strong incentives for investors and producers. However, the production and use of medical devices is subject to a number of laws, regulations, strict standards, and certification processes. Therefore, the aim of this paper is to analyze patent activity based on the example of the selected country (Czech Republic), compare it with selected foreign countries, and discuss the development of this industry in the context of new medical device regulation (MDR) implementation. The paper is based on the theoretical concept of the relationship between regulation and innovation. The main challenge in the implementation of the new medical device regulations lies in the area of innovation. This is because most innovative research in the medical device sector is undertaken by small to medium enterprises (SMEs) rather than by large companies. SMEs are more vulnerable than big companies when it comes to development because the accompanying administrative costs can be so high that it may force the company to leave the market. Given that the main reason for the existence of economic regulations are various forms of market failure, which occurs when market mechanisms do not lead to results that benefit society, any attempts to redress this situation should naturally lead to greater benefits for society and hence benefits for the given industry as well.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

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OECD FORD obor

50204 - Business and management

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2020

Kód důvěrnosti údajů

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

Název periodika

ADMINISTRATIVE SCIENCES

ISSN

2076-3387

e-ISSN

—

Svazek periodika

10

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

CH - Švýcarská konfederace

Počet stran výsledku

18

Strana od-do

"Article Number: 16"

Kód UT WoS článku

000525951500015

EID výsledku v databázi Scopus

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