New enhanced reporting requirement is to strengthen the surveillance of medical devices

A new rule imposing an enhanced reporting requirement on medical devices has just entered into force. The rule is to ensure that the surveillance of medical devices is strengthened and becomes more focused for the benefit of patients.

As of 3 March 2020, the Danish Medicines Agency may impose an enhanced reporting requirement on doctors, nurses, dentists and other healthcare professionals if a fuller picture is needed of the potential failure, errors or deficiencies in a particular type of medical device.

Medical devices are products which are used to diagnose, prevent, relieve or treat a disease, disability or injury. More than 500,000 different types of medical devices are available, covering anything from wheelchairs and glasses to pacemakers, mobile phone apps and state-of-the-art surgical equipment.

Errors in medical devices, devices that fail or are used in the wrong way could in certain cases have serious consequences for patients and the healthcare professionals who use the devices. That is why 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 incident to be serious or potentially serious.

Not just serious incidents

With the new enhanced reporting requirement, the reporting obligation does not only apply to serious or potentially serious medical device incidents. All incidents – serious and non-serious – must be reported if the Danish Medicines Agency imposes an enhanced reporting requirement on a particular type of medical device. This could happen if the Danish Medicines Agency suspects possible errors, failure or deficiencies in a medical device but needs a larger assessment basis.

The purpose of the reporting requirement is to give the Danish Medicines Agency the possibility of ensuring that all incidents are investigated thoroughly before any corrective actions are taken – 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. The manufacturer could also be required to issue a warning to users on device-related safety information or to withdraw the device from the market in the last resort. 

The enhanced reporting requirement is known from the pharmaceutical area as a means to reinforce the surveillance of pharmaceutical safety.

Should a medical device be subjected to the enhanced reporting requirement, the Danish Medicines Agency will inform all relevant stakeholders on our website.

See the new executive order on enhanced reporting requirement for medical devices at retsinformation.dk.