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SINGLE-MARKET REGULATION AND INNOVATION IN EUROPE'S MEDICAL DEVICES INDUSTRY

Published online by Cambridge University Press:  25 September 2001

Horst Steg  and
Nikolaus Thumm
Horst Steg
Affiliation:
VDI/VDE-IT-Technologiezentrum Informationstechnik GmbH
Nikolaus Thumm
Affiliation:
Institute for Prospective Technological Studies
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Abstract

In this article we analyze the influence of the legal regulatory framework in Europe, established by the two directives on medical devices and active implantable devices, on the performance of innovation in a single European market. First, we describe in general the possible influence of a single European market on innovation and the institutional features of the particular harmonization approach (“New Approach”) we are looking at here. The empirical results presented derive from a survey investigation involving 150 firms that we defined as best innovators in the European medical devices industry from a pre-survey. The results confirm that the total impact of the New Approach regulation on firms' innovation in the long term is positive. However, it also becomes clear that the impact of regulation on innovation is limited if the factors are looked at individually and that there is a clear difference regarding short-term effects. To improve the regulatory framework, several policy actions are recommended.

Keywords

European single market regulationNew Approach regulationInstitutionsInnovationMedical devices
Type
Research Article
Information
International Journal of Technology Assessment in Health Care , Volume 17 , Issue 3 , July 2001 , pp. 421 - 432
Copyright
© 2001 Cambridge University Press

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Footnotes

This article is a summary of a report compiled by VDI/VDE-IT (Teltow, Germany), Technopolis (Brighton, UK), and the Institute for Prospective Technological Studies (Seville, Spain) for the European Commission's Directorate General Enterprise. Neither the European Commission nor any person acting on behalf of the commission is responsible for the use that might be made of the information in this article. Any opinions expressed are those of the authors and not those of the European Commission, nor of the Joint Research Centre, Institute for Prospective Technological Studies, VDI/VDE-IT, or Technopolis.