ABSTRACT
This chapter examines how the European in vitro diagnostic directive (IVDD) was amalgamated with French regulations on IVD products and outlines how French policymakers adopted French regulatory practices and norms to the new European Union (EU) regime. France had already institutionalized the in vitro diagnostic product regulatory regime and applied pharmaceutical rules to diagnostic products when the EU directive on in vitro diagnostic products (IVDD) was adopted on December 8, 1998. A Commission Consultative d'Enregistrement des Re-actifs (CCER) has operated since 1995/96, when Agence du Medicament (AdM) began to enforce registration requirements and evaluate reagents. Reactovigilance is the analysis of incidents and risks associated with the use of an in vitro medical device. If reactovigilance revealed a problem, the distributor should be informed and the manufacturer should be given an opportunity to explain what happened subject to a check by laboratory specialists.
