The European Union, France, and medical devices in context
The medical device industry in Europe and France
EU policymaking on medical devices
A new public health safety policy: the same old structural problems
More restructuring of state governance
Regulation in France
The Ministry of Health: a weak, low-status player
Negotiating the EU directives in Brussels, 1990-1998
From AdM to AFSSAPS
Implementing the IVD regulatory regime
Medical device vigilance
Local operations: regulations in the hospital
Conclusion and lessons learned.