Patient safety and safe medical devices

Updated 31 January 2023

Patient safety and safe medical devices

The medical devices area is growing rapidly, and new intelligent and complex technology is constantly being developed. As part of this development, new products continuously emerge that break with the existing framework for therapy and diagnosis. While the development offers new possibilities, it also brings new challenges.

But regardless of whether the medical devices are new or old, the focal point of the Danish Medicines Agency's work remains to ensure safe medical devices and utmost patient safety. As part of our work, we monitor products on the market, review applications for clinical testing, inspect medical device manufacturers and handle device malfunction, failure and deficiencies.

Reporting of device malfunction, failure and deficiencies

A malfunctioning device – whether through failure or incorrect use – could have serious consequences. To maintain a high level of safety, manufacturers, authorised representatives, importers, distributors of medical devices as well as healthcare professionals are obliged to report every serious medical device incident that is caused by a medical device to the Danish Medicines Agency. When medical device incidents are reported to the Danish Medicines Agency, we see to it that the manufacturer investigates the cause so that we can prevent similar incidents from happening again.

European collaboration

The Danish Medicines Agency participates actively in a number of European working parties whose focus is to increase the safety of medical devices. EU countries also collaborate by exchanging information on serious medical device incidents.

Two new regulations aim to improve patient safety and ensure the availability of devices that can benefit patients’ treatment. The EU regulation on medical devices and the EU regulation on in vitro diagnostic medical devices came into force on 26 May 2021 and 26 May 2022, respectively. The new regulations tighten the rules on the marketing of new medical devices and intensify the monitoring of the market and more.


The new EU regulations

Incident reporting