The human tissues and cells competent authority concerned shall take into account the data relating to the usefulness of incorporation of the tissues or cells of human origin or their derivatives into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the established benefit-risk ratio of the addition of the tissues or cells of human origin or their derivatives in the device.
Cuirfidh údarás inniúil na bhfíochán agus na gceall daonna san áireamh na sonraí a bhaineann le húsáideacht ionchorprú na bhfíochán nó na gceall de bhunús daonna nó a ndíorthaigh san fheiste mar atá cinntithe ag an gcomhlacht dá dtugtar fógra, chun a áirithiú nach mbeidh aon tionchar diúltach ag na hathruithe ar an gcóimheas tairbhe-riosca bunaithe a bhaineann leis na fíocháin nó na cealla de bhunús daonna nó a ndíorthaigh a bheith curtha leis an bhfeiste.