Performance of a device

The IVDR splits performance into analytical performance (does the test measure correctly) and clinical performance (does the result relate to the clinical condition). Both have to support the intended purpose, though clinical performance applies only where relevant.

‘performance of a device’ means the ability of a device to achieve its intended purpose as claimed by the manufacturer. It consists of the analytical and, where applicable, the clinical performance supporting that intended purpose;

IVDR, Article 2(39)