Legislation and guidance on medical devices
The Danish Medicines Agency administers the legislation on medical devices in Denmark. We also contribute to preparing directives and guidelines on medical devices in relevant European working groups.
As a member of the EU, Denmark is obliged to implement the EU directives on medical devices into Danish legislation. They have been implemented into the Danish Act on Medical Devices and the related executive orders on medical devices.
This is an outline law giving the Danish Minister for Health the power to lay down the rules required to implement and use the European Union’s legislation on medical devices.