Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F61989100%3A27240%2F21%3A10248790" target="_blank" >RIV/61989100:27240/21:10248790 - isvavai.cz</a>

Alternative codes found

RIV/62690094:18450/21:50018087

Result on the web

<a href="https://www.frontiersin.org/articles/10.3389/fpubh.2021.666453/full" target="_blank" >https://www.frontiersin.org/articles/10.3389/fpubh.2021.666453/full</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.3389/fpubh.2021.666453" target="_blank" >10.3389/fpubh.2021.666453</a>

Result language

angličtina

Original language name

Do Regulatory Changes Seriously Affect the Medical Devices Industry? Evidence From the Czech Republic

Original language description

Background: Within the EU, some of the challenges and perceived risks now facing medical device (MD) developers result from changes in the regulatory framework, emphasizing safety. Therefore, medical technology companies must adopt stricter quality assurance measures so that individual devices can be speedily tracked and retrieved in emergency situations. Objectives: We highlight the challenges and risks faced by the European medical devices industry, particularly those faced by SMEs in the Czech Republic. We address two important research questions: Q1. Do advantages from increased regulation outweigh the additional expenses? Q2. As many MD developers are SMEs, will the new regulatory regime result in some of those companies going out of business and therefore impede future innovation? Methods: The paper focuses on a single case study, with the situation and outcomes discussed in the context of the financial results of a further 50 medical device manufacturers marketing in the Czech Republic. Results: Our findings suggest that the new legislation will result in improved safety, facilitate product recalls, but the cost and administrative burden may be high. The evidence also indicates that some SMEs may be forced to diversify to &quot;non-medical&quot; products, with the inevitable loss of innovative MDs being made available to patients and healthcare providers. (C) Copyright (C) 2021 Maresova, Rezny, Peter, Hajek and Lefley.

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

20200 - Electrical engineering, Electronic engineering, Information engineering

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

Name of the periodical

Frontiers in Public Health

ISSN

2296-2565

e-ISSN

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Volume of the periodical

9

Issue of the periodical within the volume

duben 2021

Country of publishing house

CH - SWITZERLAND

Number of pages

13

Pages from-to

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UT code for WoS article

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EID of the result in the Scopus database

2-s2.0-85105911120