Active device intended for diagnosis and monitoring means any active device used, whether alone or in combination with other devices, to supply information for detecting, diagnosing, monitoring or treating physiological conditions, states of health, illnesses or congenital deformities. A device is considered to allow direct diagnosis when it provides the diagnosis of the disease or condition in question itself or when it provides decisive information for the diagnosis.
[Definition of term as defined in MDCG 2021-24 No. 3.1.5]