Distributors' and importers' reporting

Updated 23 January 2019

Distributors and importers have an obligation to report serious incidents and accidents with medical devices to the Danish Medicines Agency. The manufacturer should also be informed of the incident with the relevant device. Please use the below form to report the incident.

Incident reporting

Manufacturer’s Incident Report

New Manufacturer's Incident Report

Guidelines

Guidelines on manufacturers' reporting of incidents with medical devices

Please send the reporting form to Medical Devices:

Email: 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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