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Medical Device Regulation

Our services for healthcare institutions and medical device manufacturers

On May 25th, the new Medical Device Regulation (hereinafter: “MDR”) has entered into force. The MDR replaces the present Medical Device Directive (hereinafter: “MDD”). As of 26 May 2021 the MDR actually applies, which means that manufacturers of medical devices must comply with the new rules as of this date. In a number of situations, an exception applies to manufacturers of medical devices who already comply with the MDD: in these specific situations, the devices can be used for a longer period of time under the conditions of the MDD. Until 2025, these special transitional provisions apply.

Technological and scientific developments lead to changes in healthcare. Software and data are increasingly being used. In addition, more and more devices are connected to each other via the internet and through the use of algorithms, such as machine learning and artificial intelligence, more and more decisions can be made or predicted automatically. These developments have been one of the reasons that the medical device legislation has been updated.

The new Regulation entails a number of major changes for both healthcare institutions and medical device manufacturers. As a healthcare institution, do you know which medical devices you use? Do you know which software products are a medical device under the Regulation? What happens if you add a functionality to purchased medical devices, or if you manufacture an in-house medical device? As a manufacturer, do you know whether your portal, medical software or other software is a medical device? What should you arrange if your digital solution must be CE-marked?

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