“European Integration and National Governance: A Comparative Analysis of the Implementation of EU Regulatory Policy on Medical Devices”

Regulatory integration is a central aspect of European integration. Yet the debate about a “European regulatory state” (Majone 1996, 1992; McGowan and Wallace 1996; Begg 1996; and Wilks 1996) largely avoids a fundamental question: who in this emerging “European regulatory state” translates the intent of EU decisions into action? Who disposes of the capacities-organizational, professional, financial, information and communication-necessary for implementing EU regulatory policy? While recent research on the role of European agencies begins to address this issue at the European level (Shapiro 1997; Majone 1997; Dehousse 1997; Kreher 1997; McGowan and Wallace 1996), the findings are often specific to the policy sector (Héritier et al. 1996; American Institute of Contemporary German Studies 1997; Vogel 1997). The following research contributes empirical information to this debate through a detailed discussion of one policy sector-medical devices