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Medical devices are classified according to the level of harm they may pose to users or patients. The following tool will assist in determining the classification of a medical device that is not an In Vitro Diagnostic device. There are separate classification rules for IVD devices.

Please read the following before you start

• Medical devices are classified according to their intended purpose, as specified by the manufacturer.

• Where a device has more than one specified purpose, the correct result will be based on the purpose with the highest classification. For example a catheter that is intended to be used short-term in peripheral arteries would be a Class IIa device. One that is intended to be used in the central circulatory system, would be a Class III device. If a manufacturer produced a catheter that was intended to be used in both the peripheral and central circulatory systems, it would be Class III because this is the highest classification for the device's intended purpose.

• Where more than one classification rule applies to the device, the correct classification is the highest classification. For example, a device used in surgery that depends on a source of energy would be covered by both 'invasive' device rules and 'active' device rules.

• Where a device is used in combination with another medical device, the classification rules must be applied separately to each device. This includes any accessories to the medical device.

• Where a medical device is driven or influenced by an item of software that is not embedded in the device, the software has the same classification as the medical device. This includes Apps on a mobile device like a smart phone or tablet.