The manufacturer shall take all the measures necessary to ensure that the manufacturing process produces devices which are manufactured in accordance with the documentation referred to in Section 2.
Déanfaidh an monaróir gach beart is gá lena áirithiú go dtáirgeann an próiseas monaraíochta feistí atá monaraithe i gcomhréir leis an doiciméadacht dá dtagraítear i Roinn 2.