Intended purpose
According to IVDR Article 2 (12) ‘intended purpose’ means the use for which a device is intended according to the data provided by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements or as specified by the manufacturer in the performance evaluation.
In Annex I Section 20.4.1 (c) the device’s intended purpose is further defined:
- what is detected and/or measured;
- its function (e.g. screening, monitoring, diagnosis or aid to diagnosis, prognosis, prediction, companion diagnostic);
- the specific information that is intended to be provided in the context of: a physiological or pathological state; congenital physical or mental impairments; the predisposition to a medical condition or a disease; the determination of the safety and compatibility with potential recipients; the prediction of treatment response or reactions; the definition or monitoring of therapeutic measures;
- whether it is automated or not;
- whether it is qualitative, semi-quantitative or quantitative;
- the type of specimen(s) required;
- where applicable, the testing population; and
- for companion diagnostics, the International Non-proprietary Name (INN) of the associated medicinal product for which it is a companion test.
Thus, the intended purpose of an IVD is the key element during the entire IVD life cycle and is the basis for the GSPRs.
