Reporting of incidents and accidents with medical devices

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