Clinical performance

Clinical performance is what the clinical or performance evaluation has to demonstrate. It sits between technical performance in the lab and the benefit to patients, and claims in the instructions for use need to match it.

‘clinical performance’ means the ability of a device, resulting from any direct or indirect medical effects which stem from its technical or functional characteristics, including diagnostic characteristics, to achieve its intended purpose as claimed by the manufacturer, thereby leading to a clinical benefit for patients, when used as intended by the manufacturer;

EU MDR, Article 2(52)

‘clinical performance’ means the ability of a device to yield results that are correlated with a particular clinical condition or a physiological or pathological process or state in accordance with the target population and intended user;

IVDR, Article 2(41)

behaviour of a medical device (3.34) and response of the subject(s) (3.50) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s) Note 1 to entry: Clinical performance can be defined under national regulations.

ISO 14155:2020, clause 3.11

The MDR describes the ability to achieve the intended purpose through direct or indirect medical effects, leading to a clinical benefit. The IVDR describes the ability to yield results correlated with a clinical condition or physiological or pathological state in the target population and intended user.