The manufacturer has therefore not reduced as far as possible the risk associated with the presence of lead in the device by selecting batches of raw material which would have made it possible to manufacture a device containing a level of lead below the threshold set by Guideline ICH Q3D.
Compte tenu de ces éléments, les autorités françaises pouvaient considérer que le dispositif ne respecte pas les exigences essentielles de la directive tenant à la minimisation des risques.