ABSTRACT
Medical device vigilance (MDV) was first mandated by the European Union (EU) in Vitro Diagnostic Directive (IVDD) in 1998. MDV concerns the investigation of incidents, near incidents, and death which have occurred with the use of medical devices in clinical practice. This chapter focuses on the implementation of EU-mandated medical device vigilance at the national level in France by distinguishing between national institutionalized roles of networks of administrative and professional-scientific stakeholders and their relations between national and local processes. From 1996 to 2000, French policymaking on medical device vigilance was driven by Europeanizing and "Francosizing" impulses. On the national level, the organization of medical device vigilance rests on two pillars, Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS), previously Agence du Medicament (AdM), and La Commission Nationale de Materiovigilance (CNMV). The modern concept materiovigilance (MV) is designed to be patient-oriented and focuses on the utilization of medical devices in clinical practice and research.
