Manufacturers' reporting of incidents with medical devices
Reporting forms and guidelines on manufacturers' reporting of incidents with medical devices and safety-related corrective actions.
Please report incidents in the following form:
Please notice that this is a new version of the manufacturer's incident report form. The new form is valid from 1. January 2020.
Reporting of safety-related corrective actions
Please send the reporting form to Medical Devices:
Mail: Send an email
Fax: +45 44 88 95 99
Danish Medicines Agency/Medical Devices
Axel Heides Gade 1
DK-2300 Copenhagen S