French tweak national law to better comply with EU's IVD (in vitro diagnostic) Directive
This article was originally published in Clinica
Executive Summary
The French health ministry has published a decree updating requirements for HIV tests in the light of the IVD Directive taking full effect on December 8 2003. The decree modifies an existing law, which is not in conformity with the IVD Directive since it requires that laboratories only use HIV tests that have been registered in France - a procedure involving heavy documentation requirements. It also requires that products must have passed specific national controls.
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