Meditsiiniseade peab olema toodetud selliselt, et selle omadused ja talitlustoime ei kahjustuks ettenähtud kasutusaja jooksul eeldusel, et järgitakse tootja juhiseid meditsiiniseadme transportimiseks ja ladustamiseks.
The devices must be designed, manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided by the manufacturer.