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Danish Medicines Agency: Newly Improved Reporting Requirement to Strengthen the Surveillance of Medical Devices


The Danish Medicines Agency recommended newly enhanced reporting requirements on medical devices to ensure that the surveillance of medical devices becomes more focused for the benefit of patients.

This new rule may impose improved reporting requirement on healthcare professionals needed to report the potential failure, errors or deficiencies in a particular type of medical device.

This new rule for reporting requirement does not only apply to serious or potentially serious medical device incidents. All incidents serious and non-serious must be reported to the Danish Medicines Agency imposes an improved reporting requirement on a particular type of medical device. 

The purpose is to ensure that all incidents are investigated thoroughly including whether the manufacturer must make changes to the device either by changing the construction of the device, the production method or the instructions for use supplied with the device. 

And the manufacturer also is required to issue a warning to users on device-related safety information or to withdraw the device from the market.