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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"

The result's identifiers

  • Result code in 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>

  • Result on the web

    <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>

Alternative languages

  • Result language

    angličtina

  • Original language name

    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"

  • Original language description

    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.

  • Czech name

  • Czech description

Classification

  • Type

    J<sub>imp</sub> - Article in a specialist periodical, which is included in the Web of Science database

  • CEP classification

  • OECD FORD branch

    30312 - Substance abuse

Result continuities

  • Project

  • Continuities

    I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Others

  • Publication year

    2023

  • Confidentiality

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

Data specific for result type

  • Name of the periodical

    INTERNATIONAL JOURNAL OF HEALTH POLICY AND MANAGEMENT

  • ISSN

    2322-5939

  • e-ISSN

    2322-5939

  • Volume of the periodical

    12

  • Issue of the periodical within the volume

    1

  • Country of publishing house

    IR - IRAN, ISLAMIC REPUBLIC OF

  • Number of pages

    4

  • Pages from-to

    "Article number: 7262"

  • UT code for WoS article

    000809599800001

  • EID of the result in the Scopus database

    2-s2.0-85154582388