Upon completing the manufacture of each batch of devices that incorporate, 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 the first subparagraph of Article 1(8), the manufacturer shall inform the notified body of the release of the batch of devices and send it the official certificate concerning the release of the batch of human blood or plasma derivative used in the device, issued by a Member State laboratory or a laboratory designated for that purpose by a Member State in accordance with Article 114(2) of Directive 2001/83/EC.
Ar mhonarú gach baisce d'fheistí a chur i gcrích, ar feistí iad 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 sa chéad fhomhír d'Airteagal 1(8), cuirfidh an monaróir an comhlacht dá dtugtar fógra ar an eolas faoi scaoileadh na baisce d'fheistí agus cuirfidh sé chuige an deimhniú oifigiúil i ndáil le scaoileadh na baisce de dhíorthach fola daonna nó plasma dhaonna atá in úsáid san fheiste, ar deimhniú é atá eisithe ag saotharlann Bhallstáit nó ag saotharlann a cheapann Ballstát chuige sin i gcomhréir le hAirteagal 114(2) de Threoir 2001/83/CE.