Batch verification in the case of devices incorporating, as an integral part, a medicinal substance which, if used separately, would be considered to be a medicinal product derived from human blood or human plasma referred to in Article 1(8).
Baisceanna a fhíorú i gcás feistí ina bhfuil substaint íocshláinte ionchorpraithe, mar chuid dhílis, a measfaí, dá mbeadh sí in úsáid ar leithligh, gur táirge íocshláinte í a díorthaíodh ó fhuil dhaonna nó ó phlasma daonna dá dtagraítear in Airteagal 1(8)