Medical devices are subject to the risk classes defined in the Medical Device Regulation (MDR). According to the Regulation (EU) 2017/745 (MDR), classification is made into four classes I, IIa, IIb and III (low to high risk in ascending order). But what exactly is the classification based on? And who has to follow it?
What counts for the time being, however, is the question: Is the product really a medical device? Or is it a non-medical device, accessory or even in vitro diagnostic device (IVD)? The answer around the definition can be found in Article 2 of the MDR.