Reporting of incidents and accidents with medical devices

Updated 27 August 2019

Medical devices could be anything from crutches to surgical instruments used in hospitals. In Denmark, there are more than 500,000 different types of devices that are of substantial benefit or even vital importance to many medical device users. 

If, on the other hand, the devices start malfunctioning or are used in the wrong way, the consequences could be serious. And for this reason, it is important that the authorities are informed if a medical device does not work as intended or if errors or other problems occur as the consequences for patients or healthcare professionals could be serious.

Healthcare professionals and manufacturers have a duty to report malfunction, failure or deficiencies

Doctors, nurses, dentists, other healthcare professionals and manufacturers have a duty to report it to the Danish Medicines Agency if they suspect a medical device malfunction, failure or deficiency.

Members of the general public can also make a report if they discover a medical device malfunction via the link below. 

At the Danish Medicines Agency, we review all reports to determine if the manufacturer should make changes to the device, update the instructions for use or if, in the last resort, the device should be recalled from the market. 

We collaborate in this matter with the authorities of other countries, including those in the EU. 

Healthcare professionals must also submit a report to the Danish Patient Safety Authority

Besides reporting device malfunction, failure and deficiencies to the Danish Medicines Agency, doctors, nurses, dentists and other healthcare professionals must also report the case as an adverse incident to the Danish Patient Safety Authority. The Danish Patient Safety Authority then investigates if the healthcare services can learn from the incident

Reporting form

Note: You have 20 minutes to complete and submit the form after you have opened it. If you spend more time, we will not receive your form.

Reporting form

The Danish Medicines Agency is the data controller in respect of the processing of the personal data we have received from you. Please find our contact details below.

Danish Medicines Agency

Axel Heides Gade 1
2300 Copenhagen S
Denmark

CVR no.: 37052485

Telephone: +45 44 88 95 95

Email: Send an email

If you have questions about our processing of your data, we advise you to contact our data protection officer.

Our data protection officer, Troels Mogensen, can be contacted in the following ways:

You have the right to lodge a complaint with the Danish Data Protection Agency if you are displeased with the way in which we process your personal data. The contact details of the Danish Data Protection Agency are available at www.datatilsynet.dk.

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