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Classification of products

14 July 2015, Updated 11 September 2015

The risks associated with using medical devices varies, which is why products are divided into four classes: I, Im (I with a measuring function), Is (I sterile), IIa, IIb and III. Class I is associated with the lowest risk, while class III is associated with the highest risk. The classification reflects the risk associated with using the product, the vulnerability of the body parts on which the device is used, and for how long the device is to be used.

In addition to the above classification of medical devices, active implantable medical devices and in vitro diagnostic devices are classified according to the rules laid down in the respective executive orders

The manufacturer is responsible for the classification of devices in accordance with the applicable legislation. For products classified higher than class I, the classification of products is carried out in collaboration with a notified body.

Examples of medical devices

Examples of medical devices are surgical instruments, insulin pumps and blood pressure meters.

Devices that are implanted into the body, e.g. hip prostheses and breast implants as well as active, implantable medical devices, such as pacemakers, are also medical devices.

In addition, medical devices cover aids for the disabled, such as wheelchairs, hoists and crutches as well as contraceptives like condoms and intrauterine devices.

Custom-made medical devices cover devices made specifically for an individual user or patient. For example, dental crowns, dental prostheses, custom-made orthopaedic footwear or glasses with individual optical strength (glasses with fixed strength are class I medical devices).

In vitro diagnostic devices are medical devices which are a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system, which are used for examination of specimens, including blood and tissue donations, derived from the human body. For example, pregnancy tests, reagents, blood glucose tests or kits for the diagnosis of virus infections such as HCV, HIV etc.

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