NLMedicalDevices object
National Act on Medical Devices
Transposition of EU Directives on MD
Other
• Act no. 1046 of 17 December 2002 on medical devices
• Active implantable medical devices:
The Ministry of Health’s executive order no. 1264 of 15 December 2008 on active implantable medical devices
• Medical Devices:
The Ministry of Health’s executive order no. 1263 of 15 December 2008 on medical devices
• In vitro diagnostic medical devices:
The Ministry of Interior and Health's executive order no. 1269 of 12 December 2005 on in vitro diagnostic medical devices
• The Danish Medicines Agency’s executive order no. 292 of 19 March 2010 on the application for the authorisation for clinical investigation of medical devices on human subjects.
It covers specific regulatory requirements for clinical investigations of medical devices
• Ethical Review:
Lov om et videnskabsetisk komitésystem og behandling af biomedicinske forskningsprojekter / Act on Research Ethics Review of Health Research Projects: unofficial translation, hereinafter referred to as the Committee Act (en)