French authority lays down its cards in In Vitro Diagnostics-Medical Devices (IVD-MD) game
This article was originally published in Clinica
The amount of information the draft IVD-MD Directive requires manufacturers to submit to Competent Authorities is inadequate, claims Dr Alain Leblanc, head of the French Medicines Agency. It would be insufficient for Competent Authorities to meet their responsibilities in the way the French Medicines Control Agency has been able to do. Dr Leblanc made these claims at a meeting this month in Antwerp, Belgium.