ABSTRACT
This chapter examines the intense circumstances surrounding the European Union (EU) in Vitro Diagnostic Directive (IVDD) directive negotiations in Brussels from 1990 to 1998. The disagreements over several drafts of the IVDD had implications for the active implantable medical device directive (AIMDD) and the MDD. Since 1993, France regulated reagents more stringently than was being discussed at the EU-level and lowering her safety and quality levels was clearly unacceptable for French negotiators and politicians. Negotiators understood that the French homologation procedure based on product type testing was limited because evidence of quality and clinical investigations were not required. On the domestic front, the French Agence du Medicament (AdM) was reorganized in the mid-1990s and a new draft decree was being prepared to strengthen the regulatory framework for reactifs. These activities also coincided with a major problem involving diagnostic products going back to 1993-1994.
