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Rules - IVDD The Vigilance SystemThe Danish Medicines Agency has, for the purpose of carrying out vigilance, established a mandatory reporting system for serious incidents and accidents that may occur in connection with the use of medical devices.The obligation to report applies to both manufacturers and users, including hospitals. Manufacturers are only under an obligation to report the defects that come to their attention about the product itself, the labeling or the instructions for use. The manufacturers are therefore dependent on efficient market feedback from their customers. Users, on the other hand, must report any defects that relate to the product itself, the labeling or the instructions for use as well as serious incidents and accidents due to misuse or incorrect maintenance or adjustment. If the Danish Medicines Agency finds that certain medical devices pose a risk to patients, users or others, the agency may restrict or prohibit the marketing of the product and possibly require that it is recalled from the market. Back to index |
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