Medical devices are divided into four classes: I, IIa, IIb, and III. This classification is based on risk: the higher the risk to the patient if the medical device fails, the higher the class. The higher the device's class, the more stringent the scrutiny process will be.
To determine the risk of the use of a device and therefore which class is applicable, the intended medical purpose is used. Based on the intended purpose, the applicable MDR classification rules are determined. In total there are 13 classification rules and 9 special rules, which together determine the risk class. The quick scan classification provides an initial estimate of the correct class.