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[European Community procedure of marking for a reagent. Application to HIV 1 and 2 detection kits]
K Bénichou-Debasc1, A Gautheret-Dejean2
1Service de virologie, Hôpital Pitié-Salpêtrière, AP-HP.
Abstract:
Kits for the detection of HIV infection are in vitro-diagnostic medical devices and are subject to special regulation to be marketed in the European Community. Before 1998, the Agence française de sécurité sanitaire des produits de santé was responsible for evaluating the new kits before allowing their marketing in France. The publication in the Official Journal of the European Community (L331 of December 7, 1998) of the European directive 98/79/CE of October 27, 1998 on in vitro diagnostics medical devices has changed the procedure for marketing approval of these kits in Europe. The aim of this review is to present the relevant conformity assessment procedures and its latest updates.
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