Medical devices and in vitro diagnostic medical devices produced in a third country and imported into the EU are subject to the same rules as medical devices produced within the EU.
Meditsiiniseadmete ja in vitro diagnostikameditsiiniseadmete suhtes, mis on toodetud kolmandas riigis ja ELi imporditud, kohaldatakse täpselt samu reegleid, mis ELis toodetud seadmetegi suhtes.