Manufacturers' reporting of incidents with medical devices

Reporting forms and guidance for manufacturers on the reporting of medical device incidents and field safety corrective actions.

Incident reporting

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

Field Safety Notice

Guidance

Guidance for manufacturers on the reporting of medical device incidents

How to use FSCA and MIR forms

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
Denmark