The manufacturer shall ensure that the quality management system approved for the manufacture of the devices concerned is implemented, shall carry out final verification, as specified in Section 3, and shall be subject to the surveillance referred to in Section 4.
Áiritheoidh an monaróir go gcuirtear i bhfeidhm an córas bainistithe cáilíochta a formheasadh chun na feistí lena mbaineann a mhonarú, déanfaidh sé an fíorú deiridh, mar a shonraítear i Roinn 3 í, agus beidh sé faoi réir an fhaireachais dá dtagraítear i Roinn 4.