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"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 (Unpublished)

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    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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    Item Type: Conference or Workshop Item (UNSPECIFIED)
    Subjects for non-EU documents: Countries > U.K.
    EU policies and themes > Policies & related activities > public health policy (including global activities)
    EU policies and themes > Policies & related activities > regulations/regulatory policies
    Countries > France
    Countries > Germany
    EU policies and themes > Policies & related activities > law & legal affairs-general (includes international law) > compliance/national implementation
    Subjects for EU documents: UNSPECIFIED
    EU Series and Periodicals: UNSPECIFIED
    EU Annual Reports: UNSPECIFIED
    Conference: European Union Studies Association (EUSA) > Biennial Conference > 2003 (8th), March 27-29, 2003
    Depositing User: Phil Wilkin
    Official EU Document: No
    Language: English
    Date Deposited: 18 Feb 2005
    Page Range: p. 30
    Last Modified: 15 Feb 2011 17:24

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