In the case of devices that incorporate a medicinal substance, including a human blood or plasma derivative or devices manufactured utilising non-viable tissues or cells of human or animal origin, or their derivatives, detailed information on the medicinal substance or on the tissues, cells or their derivatives, and on the compliance with the relevant general safety and performance requirements and the specific risk management in relation to the substance or tissues, cells or their derivatives, as well as evidence for the added value of incorporation of such constituents in relation to the clinical benefit and/or safety of the device.
I gcás feistí ina bhfuil substaint íocshláinte ionchorpraithe, lena n-áirítear díorthach fola daonna nó plasma dhaonna nó feistí a mhonaraítear agus úsáid á baint as fíocháin nó cealla neamh-inmharthana de bhunús ainmhíoch nó a ndíorthaigh, faisnéis mhionsonraithe ar an tsubstaint íocshláinte nó ar na fíocháin, na cealla nó ar a ndíorthaigh, agus ar an gcomhréireacht leis na ceanglais ghinearálta sábháilteachta agus feidhmíochta ábhartha agus an bhainistíocht shonrach riosca maidir leis na tsubstaint nó leis na fíocháin, nó maidir leis na cealla, nó lena ndíorthaigh, chomh maith le fianaise don bhreisluach a bhaineann le comhábhair den sórt sin a ionchorprú le sochar cliniciúil agus/nó le sábháilteacht na feiste.