Adverse events/serious incidents that occur with the use of any medical device must be reported to the Danish Medicines Agency. The report will then be fully investigated with the manufacturer, the authorised representative or the appointed distributor. The purpose is to determine the probable cause of the event and to provide advice or corrective action to prevent further occurences of a similar nature. In some justified cases this may require the manufacturer to remove a specific product from the users or marketplace.
The obligation of reporting adverse incidents applies to manufacturers, professional users and other healthcare professionals.
Supplementary information regarding the systems for reporting of adverse incidents is provided in the EU Commission's Guidelines on a medical devices vigilance system MEDDEV 2.12-1.
Reporting methods:
Electronic forms: |
