Protseduur «Tootmiskvaliteedi tagamine» on toiming, mille kaudu tootja tagab asjaomase meditsiiniseadme tootmiseks kinnitatud kvaliteedisüsteemi elluviimise, nagu on sätestatud paragrahvides 177–180, kusjuures tema tegevus peab olema allutatud paragrahvides 181–182 kirjeldatud järelevalvele.
... before equipment is placed on the market and according to the choice made by the manufacturer or his authorized representative established within the Community from the possibilities indicated in Annex A.1, all equipment shall be subject to:
(a) the EC declaration of conformity to type (module C);
(b) the EC declaration of conformity to type (production-quality assurance) (module D) ...
