Medical Device Classification
The new MDR 2017/745, which came into effect on 26 May 2021, categorizes medical devices into classes: Class I, Class II a, class II b, and class III. This classification is based on the 22 rules in the new MDR 2017/745.
Rules 1-4 for Non–invasive devices, rules 5-8 for Invasive devices, rules 9 -13 for Active devices, and rules 14-22 are Special rules.
Invasive devices, in whole or part, penetrate inside the body either through a body orifice or through the body’s surface. Non- Invasive device means it does not enter the body. The surgically invasive device always implies that it enters through an artificially created opening. Examples of surgically invasive devices are surgical gloves and needles used with syringes. Active devices transform and inject power or energy into a circuit. Examples of active devices are vacuum tubes, transistors, and Infusion pumps.
The new MDR classification reflects the potential risk of harm that a medical device poses. Based on risk, medical devices are ranked from class I for the lowest-risk devices to class III for the highest risk.
- Class, I medical devices are devices with low or moderate risk to patient health and safety. All non-invasive devices are classified as class I. In many cases, the manufacturer can self-certify the class I devices without the involvement of a notified body. Examples of class I devices include products like a stethoscope, wheelchair, bandages, spectacle, etc.
- Class I is again subcategorized into three more sub-classifications. These classifications are class I m, class I r, & class I s. Devices that have measuring function is classified as class I m category. Devices reusable like surgical instruments are categorized as class I r category. Devices that must be presented sterile are Class I s category. These are low to medium-risk categories and require the involvement of notified body before the manufacturer can affix the CE marking.
- Class IIa medical devices are considered a medium risk by the MDR. The notified body certifies this class of medical devices through conformity assessment. Examples of class II devices include catheters, hearing aids, short-term contact lenses, etc.
- Class II b medical devices are considered medium-high risk under the MDR. Class II b devices require a conformity assessment. This risk class includes devices like incubators, insulin pens, long-term contact lenses, etc.
- Class III medical devices are considered high-risk devices. Examples of class III medical devices include Pacemaker.
Irrespective of the class of the device, all devices must comply with all the relevant obligations of the new MDR. But we need to understand that some of these requirements depend on the device classification. Hence, proper classification of medical devices is one of the most important accept of CE marking.