Protseduur «Tootekvaliteedi tagamine» on toiming, mille kaudu tootja tagab kinnitatud kvaliteedisüsteemi elluviimise meditsiiniseadme lõppkontrolliks ja testimiseks kooskõlas paragrahvide 189–193 nõuetega, kusjuures selle järelevalve peab toimuma kooskõlas paragrahvide 194 ja 195 nõuetega.
... 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);
(c) the EC declaration of conformity to type (product-quality assurance) (module E) ...
