Altenstetter, Christa. (2001) "Multi-level implementation networks: The case of medical devices and patient care". In: UNSPECIFIED, Madison, Wisconsin. (Unpublished)
One objective of this paper is to understand the nature and the role of policy networks and multi-level regulatory decision-making systems in the field of medical devices, their composition and activities in a global context. The emphasis is on reconstructing the basic structure of the actors involved in multi-level regulatory processes rather than a systematic examination of the structure of each network type. This paper grows out of an ongoing cross-national research project entitled “Regulatory Regimes in Transition: The Medical Device Sector and Patient Care.” In 1995, it started out as an exploration of the implementation of regulatory policy specific to medical devices in the European Union, focusing on two levels of rule-making and rule-application and drawing a distinction between the formulation of policy and operations to carry it out: 1) the EU level of rule-making and implementation, and 2) the level of national and sub-national implementation. Through focused case studies of domestic implementation in France, Germany, and the United Kingdom, the crossnational comparison has intended to identify similarities and differences in the implementation of European legislation, and shed light on the strengths and weaknesses of their responses at both the policy and levels of implementation from national to local.
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