Patient safety and safe medical devices

Updated 12 October 2020

The medical devices area is fast-growing, and new technology which is both intelligent and complex is constantly being added. 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 DKMA'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, importers and 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 DKMA. When medical device incidents are reported to the DKMA, we see to it that the manufacturer investigates the cause so that we can prevent similar incidents from happening again.

European collaboration

The DKMA participates actively in a number of European working parties whose focus is to increase the safety of medical devices. Work is also in progress to establish a cooperation procedure for the exchange of information about serious medical device incidents between the European member states.

New medical device regulations have been adopted and will take effect on 26 May 2021. The regulations aim to improve patient safety and ensure the availability of devices that can benefit patients. The new regulations tighten the rules on the marketing of new medical devices and intensifies the monitoring of the market and more.

Links

Incident reporting

The new EU regulations

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