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"Regulating Healthcare Technologies and Medical Supplies: A Comparative Overview"

Altenstetter, Christa. (1995) "Regulating Healthcare Technologies and Medical Supplies: A Comparative Overview". In: UNSPECIFIED, Charleston, South Carolina. (Unpublished)

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    A complex relationship exists among EU regulations, current national practices and rules, institutional capacities to implement regulatory adjustments and the legacy of past health and regulatory policy and traditions. However, there is little empirical information on medical devices policy, the medical devices industry, and the assurance of medical device safety and usage. Drawing on a review of the secondary literature and on-going field work, the evidence suggests that the current mix of statecentric and self-regulatory traditions will be as important in determining the implementation and final outcomes of EU-rules as the new rules themselves. EU directives redesign rules, but they do not necessarily lead to institutional change, create institutional capacities, or alter old practices in the short term. Neither EU directives nor national regulatory adjustments determine the "man-machine/skill-experience" interface which is shaped and influenced by local medical traditions and the acceptance of these traditions by local publics.

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    Item Type: Conference or Workshop Item (UNSPECIFIED)
    Subjects for non-EU documents: EU policies and themes > Policies & related activities > public health policy (including global activities)
    EU policies and themes > Policies & related activities > regulations/regulatory policies
    Subjects for EU documents: UNSPECIFIED
    EU Series and Periodicals: UNSPECIFIED
    EU Annual Reports: UNSPECIFIED
    Conference: European Union Studies Association (EUSA) > Biennial Conference > 1995 (4th), May 11-14, 1995
    Depositing User: Phil Wilkin
    Official EU Document: No
    Language: English
    Date Deposited: 14 Apr 2007
    Page Range: p. 20
    Last Modified: 15 Feb 2011 17:45

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