Class of a Medical Device

The risk class of a medical device is assigned based on the degree of impact, type, and duration of interaction with the patient. Classification involves ranking according to the level of risk to the user’s or patient’s health and life.

Classification criteria are always guided by the intended purpose of the medical devices.

The classification criteria are specified in Annex 2 to Technical Regulation No. 753.

There are 4 risk classes: I, IIa, IIb, and III, where Class I denotes the lowest risk and Class III denotes the highest risk.

For in vitro medical devices, these include in vitro devices listed in List A and List B, and they may be for self-testing or not for self-testing.