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MEDICAL DEVICES
LEGISLATION AND GUIDANCE
INCIDENT REPORTING
PLACING ON THE MARKET
CLINICAL INVESTIGATION
LANGUAGE REQUIREMENTS
DANISH MEDICINES AGENCY
medicaldevices.dk > Danish Medicines Agency  >
Work activities

The agency'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.
Last update 10.10.2005 Print this page