The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out a final verification, as specified in Section 6, and shall be subject to the surveillance referred to in Section 7.
Áiritheoidh an monaróir go gcuirtear an córas bainistithe cáilíochta a formheasadh chun na feistí lena mbaineann a mhonarú a chur chun feidhme, déanfaidh sé an fíoru deireanach, mar a shonraítear i Roinn 6 í, agus beidh sé faoi réir an fhaireachais dá dtagraítear i Roinn 7.