III klassi meditsiiniseadme, välja arvatud tellimusmeditsiiniseade ja uuringumeditsiiniseade, vastavushindamisel järgib tootja: 1) paragrahvides 138–156 kirjeldatud protseduuri «Täielik kvaliteeditagamise süsteem» ...
EC declaration of conformity (Full quality assurance system)
1. The manufacturer must ensure application of the quality system approved for the design, manufacture and final inspection of the products concerned, as specified in Section 3 and is subject to audit as laid down in Sections 3.3 and 4 and to Community surveillance as specified in Section 5.
