Diagnosis

Diagnosis is one of the medical purposes in the device definition, so this description helps decide whether a product is a medical device. Because it includes visualisation, detection and measurement, a product that measures a body function for interpretation can have a medical purpose even if it gives no diagnosis itself.

‘Diagnosis’ is the process of investigation of the anatomy, morphology, the condition or the functions of the human body irrespective if these are physiological or pathological, and subsequent interpretation of this information with a view to determining possible abnormalities. In this context investigation can include visualisation, detection or measurement.

MDCG 2022-5 Rev.1, Section 1.2.3, Definition of medical diagnosis