"Bridging EU and domestic implementation: A cross-national comparison"

Altenstetter, Christa. (2003) "Bridging EU and domestic implementation: A cross-national comparison". In: UNSPECIFIED, Nashville, TN. (Unpublished)

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Abstract

This paper tackles a topic of interdisciplinary interest and current policy importance in countries around the world: the regulation of safe efficacious and quality medical devices for use in patient care. Regulation in the field is thirty years behind the regulation of medicines in the European Union, and thirty years behind medical device regulation in the U.S. Specifically, the paper looks at the implementation of three medical device directives in France, Germany, and the United Kingdom, through the lens of domestic implementation literature, evolving over a period of thirty years. The central concerns of this literature arguably coincide with many of the concerns and distinctive features of the historical and sociological version of the new institutionalism rather than rational choice. Questions are raised about the significance of domestic constraints and opportunities in adapting to EU directives on medical devices. What kinds of domestic policy and contextual constraints and opportunities exist? How do they affect the domestic implementation process? What are the domestic outcomes? And, finally, how do we explain variations in outcomes of implementing the same EU directives on medical devices across the three countries?

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