ABSTRACT
The European Union (EU) and French developments characterize the fundamental changes taking place concerning the conditions influencing regulatory governance. In addition, these developments expose a shift in the power relationships among public and private actors that occurred in response to international pressures to create a "single regulatory window" for medical devices and in vitro diagnostic medical devices. The French record on local medical device vigilance operations calls for greater attention to the grey zones that exist between law and medicine, medicine and pharmacy, as well as biomedical engineering. In light of growing pressures supporting the global harmonization of universal safety standards and the increasing concerns over the regulatory and commercial implications of global trade with medical devices, it is justified to contrast and compare French findings against recent international developments and debates. The global harmonization of ex ante solutions between 1998 and the present has been astonishingly rapid.
