The medicinal products authority consulted shall take into account the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body, in order to ensure that the changes have no negative impact on the risk or benefit previously established concerning the incorporation of the substance into the device.
Cuirfidh an t-údarás um tháirgí íocshláinte a ndeachthas i gcomhairle leis san áireamh na sonraí a bhaineann le húsáideacht ionchorprú na substainte san fheiste mar atá cinntithe ag an gcomhlacht dá dtugtar fógra, chun a áirithiú nach mbeidh aon tionchar diúltach ag na hathruithe ar an riosca nó ar an tairbhe a bunaíodh roimhe sin a bhaineann leis an tsubstaint a ionchorprú san fheiste.