ABSTRACT
This chapter traces medical device product regulation in France prior to European Union (EU) regulation. This analysis reveals that, despite the modernization of state governance and health infrastructures, institutionalized roles, relations, and practices did not change much. Homologation, a cumbersome process driven entirely by administrative stalemate and French legal traditions, forced public health officials to be more pragmatic in their administrative practices. Path-dependent patterns of representation, distribution of influence, and scientific advice giving by the National Commission on Medical Device Vigilance (CNMV) followed the same representational patterns favored under homologation. The ministry of health became the lead agency responsible for all aspects of the homologation process. The ministry of health appointed test laboratories after consultation with the Commission Nationale d'Homologation (CNH) and the ministry of industry. They are authorized to conduct the necessary laboratory tests and prepare the final reports.
