MDR - Medical Device Regulation

In May 2021 a new stricker regulation for medical devices (Medical Device Regulation - MDR) came in effect. The MDR applies to medical devices and products used for diagnoses and treatments in the healthcare sector or products that can help prevent or predict disease or disorders. These include devices like bandages, pacemakers and surgical instruments but importantly also include software like medical apps. The MDR therefor has a huge impact on App and medical software developers. Manufactures and developers of such medical devices and software most comply with the legal requirements of the MDR. The relevance for data exchange and data sharing applies for medical software that need to do a medical evaluation or need to do a clinical investigation. This need depends on the classification of the medical device (or software). In the MDR medical devices are classified according to the risk there is for the patient. In the MDR four categories are identified:

• I - Medical devices with low risk (non-sterile and/or non measuring, like bandage etc)

• IIa - Medical devices with moderate risk

• IIb - Medical devices with moderate to high risk

• III - Medical devices that come into direct contact with the heart, the central circulatory system or the central nervous system
  

For class I medical devices (non-sterile and/or non-measuring) no certificiation is needed. For higher risk class Medical Devices like software and health apps, the product needs to be certified. For this medical evaluation or clinical investigation has to be conducted. The Dutch goverment published a simplified guideline for MDR. In the document also information is provided about CE marking that is obliged for every medical device or medical software on the European market. Inspection of medical devices and medical software with a classification above I must be inspected by a Notified Body. This authority can approve medical devices for CE certificates.

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