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

Result code in 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>

Result on the web

<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>

Result language

angličtina

Original language name

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

Original language description

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.

Czech name

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Czech description

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Type

J_imp - 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

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Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2020

Confidentiality

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

Name of the periodical

ADMINISTRATIVE SCIENCES

ISSN

2076-3387

e-ISSN

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Volume of the periodical

10

Issue of the periodical within the volume

1

Country of publishing house

CH - SWITZERLAND

Number of pages

18

Pages from-to

"Article Number: 16"

UT code for WoS article

000525951500015

EID of the result in the Scopus database

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