When issuing its opinion, the medicinal products authority consulted shall take into account the manufacturing process and the data relating to the usefulness of incorporation of the substance into the device as determined by the notified body.
Agus a thuairim á heisiúint aige, cuirfidh an t-údarás um tháirgí íocshláinte a ndeachthas i gcomhairle leis san áireamh an próiseas monaraíochta agus na sonraí a bhaineann le húsáideacht ionchorprú na substainte san fheiste mar atá cinntithe ag an gcomhlacht dá dtugtar fógra.