Risk Classes of Medical Devices

How Are Medical Devices Classified into Risk Classes?

► Depending on the level of health risk posed by their use to the user or another person (e.g. an operator), medical devices are divided into risk classes I, IIa, IIb, and III, with Class I comprising the lowest-risk medical devices. The risk class of a medical device is determined by the manufacturer when placing the device on the market, in accordance with the classification rules laid down by the relevant implementing legislation. You can verify the risk class of a medical device here by checking column 6.

► Class I represents the lowest risk, while Class III represents the highest risk. Classification depends on factors such as the duration of contact with the body, invasiveness, and the intended purpose of the device.

Overview of Risk Classes and Examples:

► Class I (low risk) – non-invasive devices

Examples: bandages, crutches, compression stockings, instruments, orthoses, toilet seat raisers, special footwear, shoe insoles, ...

► Class IIa (moderate risk) – short-term invasive devices and diagnostic devices

Examples: inhalation devices and accessories, suction devices, syringes, blood pressure monitors, thermometers, ...

► Class IIb (higher moderate risk) – life-support and life-sustaining devices

Examples: defibrillators, ventilators, contact lenses, orthopedic implants, ...

► Class III (high risk) – implants for the cardiovascular or nervous system and devices containing medicinal substances

Examples: pacemakers, artificial heart valves, medicinal plasters, ...

In Vitro Diagnostic Medical Devices (IVDs)

An in vitro diagnostic medical device (IVD) is a medical device that is a reagent, reagent reaction product, calibrator, control material, kit, instrument, apparatus, equipment, software, or system, used alone or in combination and intended by the manufacturer for the in vitro examination of specimens, including donated blood and tissues obtained from the human body, primarily or exclusively for the purpose of obtaining information about:

• a physiological or pathological process or condition,
• congenital physical or mental impairments,
• predisposition to a particular medical condition or disease,
• safety and compatibility with potential recipients,
• predicting responses to treatment,
• determining and monitoring therapeutic measures.

► Specimen containers are also considered in vitro diagnostic medical devices.

Accessories for medical devices or IVDs are not themselves medical devices or IVDs, but are used together with them to enable or directly contribute to their intended use. They are also subject to regulations applicable to medical devices (e.g. ultrasound gels, contact lens solutions, and lubricants intended for use with medical devices such as gloves, endoscopes, or condoms).