Manufacturers' reporting of incidents with medical devices

Updated 23 January 2019

Reporting forms and guidelines on manufacturers' reporting of incidents with medical devices and safety-related corrective actions.

Incident reporting

Manufacturer’s Incident Report

New Manufacturer's Incident Report

Reporting of safety-related corrective actions

Field Safety Corrective Action

Field Safety Notice

Guidelines

Guidelines on manufacturers' reporting of incidents with medical devices

Please send the reporting form to Medical Devices:

Mail: Med-udstyr@dkma.dk
Fax: +45 44 88 95 99
Letter:
Danish Medicines Agency/Medical Devices
Axel Heides Gade 1
DK-2300 Copenhagen S

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