Changes in the classification of healthcare software

In the MDR there is no special change for embedded software products; they follow the classification of the device of which they are a part.

On the contrary standalone medical software are classified on their own right and here the MDR introduces significant changes compared to the MDD. The new classification rules are moved into the higher risk classes II or III, as indicated in the following table where we differentiate between standalone SW excluded by the definition of medical device and embedded SW products considered as “medical devices”.

Please note that the new EU Medical Device Regulation 2017/745 (MDR) recognizes and regulates Clinical Decision Support (CDS) Systems as «medical devices». On the contrary of 21st Century Cures Act (FDA regulation) such products are all considered medical devices regardless if their outcomes represent or not the exclusive tool used by medical professionals to make a clinical diagnosis or treatment decision.