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Rules - MDD Advantages for UsersDenmark has never before had legislation that governs the safety of special medical devices. However, the Medical Device Directive and the Danish implementation of the Directive have compensated for this inadequacy.When purchasing CE-marked products the users will obtain medical devices with well-documented compliance of wide-ranging requirements for functions and safety. Also, the concept of manufacturer will be unambiguously defined so that the labeling leaves the end user with no doubt as to who is responsible for the product. Unambiguous rules on instructions for use, including the requirement that they must be available in Danish and a number of languages of other member states, will also ensure improved safety when using the product. Back to index |
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