Impact of Regulatory Changes on Innovations in the Medical Device Industry; Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It?- A Viewpoint Paper"

Kód výsledku v IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F62690094%3A18450%2F23%3A50019222" target="_blank" >RIV/62690094:18450/23:50019222 - isvavai.cz</a>

Výsledek na webu

<a href="https://www.ijhpm.com/article_4278.html" target="_blank" >https://www.ijhpm.com/article_4278.html</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.34172/ijhpm.2022.7262" target="_blank" >10.34172/ijhpm.2022.7262</a>

Jazyk výsledku

angličtina

Název v původním jazyce

Impact of Regulatory Changes on Innovations in the Medical Device Industry; Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It?- A Viewpoint Paper"

Popis výsledku v původním jazyce

Economic regulation is an instrument of the state or other institutions to correct market failures, rectify the business environment, or protect consumers. Regulation can be a major driver of innovation, and it has proven to be so in the past. On the other hand, there are also documented cases of ineffective regulation due to information delays or shortcomings in government decision-making. The complexity of the impact of regulatory changes on innovation can currently be observed in the medical device market in Europe. Regulation (EU) 2017/745 whose main idea is to ensure greater safety and health protection for consumers, is a challenge for originator, manufacturer, mostly small and medium-sized enterprises. The regulation is associated with an increase in the cost of developing and maintaining the product on the market. We can now gradually begin to analyze whether it can be ranked among those that have become drivers of innovation.

Název v anglickém jazyce

Impact of Regulatory Changes on Innovations in the Medical Device Industry; Comment on "Clinical Decision Support and New Regulatory Frameworks for Medical Devices: Are We Ready for It?- A Viewpoint Paper"

Popis výsledku anglicky

Economic regulation is an instrument of the state or other institutions to correct market failures, rectify the business environment, or protect consumers. Regulation can be a major driver of innovation, and it has proven to be so in the past. On the other hand, there are also documented cases of ineffective regulation due to information delays or shortcomings in government decision-making. The complexity of the impact of regulatory changes on innovation can currently be observed in the medical device market in Europe. Regulation (EU) 2017/745 whose main idea is to ensure greater safety and health protection for consumers, is a challenge for originator, manufacturer, mostly small and medium-sized enterprises. The regulation is associated with an increase in the cost of developing and maintaining the product on the market. We can now gradually begin to analyze whether it can be ranked among those that have become drivers of innovation.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30312 - Substance abuse

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2023

Kód důvěrnosti údajů

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

Název periodika

INTERNATIONAL JOURNAL OF HEALTH POLICY AND MANAGEMENT

ISSN

2322-5939

e-ISSN

2322-5939

Svazek periodika

12

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

IR - Íránská islámská republika

Počet stran výsledku

4

Strana od-do

"Article number: 7262"

Kód UT WoS článku

000809599800001

EID výsledku v databázi Scopus

2-s2.0-85154582388