Section 4: Conditions for entry into or exit from national territory of elements or products of the human body mentioned in Article R. 1245-1 intended for the manufacture of in vitro diagnostic medical devices

Manufacturers of in vitro diagnostic medical devices may import or export tissues, their derivatives and cells from the human body, whatever their level of processing, when these products are intended for the manufacture of in vitro diagnostic medical devices meeting the requirements to which they are subject for their marketing. The manufacturers concerned must declare their import activity to the Director General of the Agence nationale de sécurité du médicament…