Indication / indication for use

MDCG separates the indication from the intended purpose, which describes the device's effect. Not every device has an indication, but when it has one, the clinical evaluation must support it.

• ‘indication’, ‘indication for use’: refers to the clinical condition that is to be diagnosed, prevented, monitored, treated, alleviated, compensated for, replaced, modified or controlled by the medical device. It should be distinguished from ‘intended purpose/intended use’, which describes the effect of a device. All devices have an intended purpose/intended use, but not all devices have an indication (e.g. medical devices with an intended purpose of disinfection or sterilisation of devices).

MDCG 2020-6, Section 1.2, Additional terms not defined in MDR Article 2