Subsection 1: Provisions relating to the import and export of elements or products of the human body mentioned in Article R. 1245-1 from or to countries outside the European Union and the European Economic Area and 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…