Manufacturers' reporting of incidents with medical devices
Updated 20 June 2022
Reporting forms and guidance for manufacturers on the reporting of medical device incidents and field safety corrective actions.
Incidents must be reported using the form below:
New Manufacturer's Incident Report
Please note that this is a new version of the reporting form effective as of 1 January 2020.
Reporting of field safety corrective actions
Field Safety Corrective Action
Guidance for manufacturers on the reporting of medical device incidents
Click here to find more templates and guidance on how to use the templates
The reporting forms are to be submitted to the Medical Devices department.
E-Mail: Send an email. +45 44 88 95 99
Letter: Danish Medicines Agency/Medical Devices
Axel Heides Gade 1
2300 Copenhagen S