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:

Manufacturer's Incident Report 

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

Manufacturer incident report Helptext 2020

MDCG 2023-3 - Questions and Answers on vigilance terms and concepts as outlined in the Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746

Click here to find more templates and guidance on how to use the templates

The reporting forms are to be submitted to the Department of Medical Devices.

E-Mail:   Send an email

Phone:  +45 44 88 95 99

Letter:

Danish Medicines Agency/Medical Devices
Axel Heides Gade 1
2300 Copenhagen S
Denmark