Clinical benefit

Under the EU rules the benefit has to be stated in terms that can be measured, and the clinical evaluation has to show it. A vague benefit such as improving care makes the benefit-risk conclusion hard to support.

‘clinical benefit’ means the positive impact of a device on the health of an individual, expressed in terms of a meaningful, measurable, patient-relevant clinical outcome(s), including outcome(s) related to diagnosis, or a positive impact on patient management or public health;

EU MDR, Article 2(53)

‘clinical benefit’ means the positive impact of a device related to its function, such as that of screening, monitoring, diagnosis or aid to diagnosis of patients, or a positive impact on patient management or public health;

IVDR, Article 2(37)

The MDR describes the benefit as a meaningful, measurable, patient-relevant clinical outcome. The IVDR links it to the device's function, such as screening, monitoring or diagnosis, since an IVD's benefit comes through the information it provides.