Sitemap

• Legislation and Guidance
  • Legislation for medical devices
  • Guidances from the Danish Medicines Agency
  • Commission Guidance Documents
  • European Directives
  • Other regulation
• Incident reporting
  • Sikkerhedsmeddelelser
• Placing on the market
  • Certificates of Free Sale
  • Registration of manufacturers and authorised representatives
    • No registration requirement for foreign manufacturers
• National requirements
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• Clinical investigations
  • Regulatory requirements for clinical investigations
  • Application for clinical investigations
    • Amendments to a Clinical Investigation
  • Fees for clinical investigations
• About medical devices
  • Work activities related to medical devices
  • Reuse of data in e-forms