Are used for the measurement of the analyte (measurand) levels for the purpose of adjusting treatments/interventions as required. Devices for monitoring include the following:
- Devices which are used to assess whether an analyte remains within physiological levels or within an established therapeutic drug range. These types of devices are designed to evaluate an individual’s current state.
- Devices which are used for serial measurement, whereby multiple determinations are taken over time. These types of devices are typically used for the detection/assessment of disease progression/regression, disease recurrence, minimum residual disease, response/resistance to therapy, and/or adverse effects due to therapy. These types of devices are designed to evaluate changes in an individual’s state.
[Definition according to MDCG 2020-16 rev.1 No. 2]