ABSTRACT
The ministry of health's mission in regulatory governance of health product safety is the endpoint of a long process of institutional engineering and restructuring culminating in legislation in August 2004. This chapter focuses on the role of the ministry of health in the adaptation processes in France starting with the active implantable medical device directive (AIMDD), the MDD, and the in vitro diagnostic directive (IVD) directive adopted by the European Union (EU) institutions in the 1990s. The AIMDD provoked severe criticism from a range of key stakeholders who did not trust manufacturer self-certification. The broad scope of the MDD covering all medical devices intensified the controversy surrounding self-certification by manufacturers, conformity assessment, and quality assurance. Following the literature on French elites franco-francais appears to be normal behavior within the hierarchy of administrative elites. Inward-looking attitudes are in large part the result of bureaucratic processes, embedded in routinized administrative practices.
