Medical Devices Directive
Manufacturers and authorised representatives based in Denmark placing class I, custom made devices, systems and procedure packs on the market are required to register at the Danish Health and Medicines Authority providing details of themselves and the medical devices.
This also applies to sterilizers of systems and procedure packs or other CE marked medical devices designed by the manufacturer to be sterilised before use.
Danish manufacturers and authorised representatives placing new class I devices and systems and procedure packs on the market as of 1 May 2011 shall register the devices at the Danish Medicines Agency.
In Vitro Diagnostic Medical Devices Directive
Manufacturers and authorised representatives based in Denmark placing products on the market are required to notify the Danish Health and Medicines Authority on details of themselves and the in vitro diagnostic medical devices (IVD) they are placing on the market.
