When issuing its opinion, the EMEA shall take into account the manufacturing process and the data related to the usefulness of the incorporation of the substance into the device as determined by the notified body.
Izsniedzot atzinumu, EMEA ņem vērā ražošanas procesu un datus par vielas iestrādāšanas ierīcē lietderīgumu, kā to noteikusi pilnvarotā iestāde.