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Work activities related to medical devices

The Danish Health and Medicines Authority's work activities include:

  • implementation and enforcement of the regulations for medical devices 
  • investigation of adverse/serious incident reports from manufacturers and users
  • operating the vigilance system for notifications affecting medical devices on the market
  • designating and monitoring of the notified bodies in Denmark 
  • contributing to the European work programmes for the safety and quality of medical devices
  • provision of advice to users, manufacturers and interested parties
  • maintaining the register of Danish manufacturers of Class I, custom made devices and procedure packs
  • issuing export certificates to Danish manufacturers of medical devices.
Created 09 November 2004, Updated 15 December 2011