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.
|