What is the difference between the performance, clinical performance and clinical benefit?
In accordance with the MDR, the performance of a device is its ability to achieve its intended purpose as stated by the manufacturer, and may relate to the user of the device.
By extension, the clinical performance of a device is the ability of the device to achieve its intended purpose, thereby leading to a clinical benefit when used as intended.
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.
References:
- MDR Article 2(22)
- MDR Article 2(52)
- MDR Article 2(53)
- MDCG 2021-6 Q&A Dec23
By extension, the clinical performance of a device is the ability of the device to achieve its intended purpose, thereby leading to a clinical benefit when used as intended.
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.
References:
- MDR Article 2(22)
- MDR Article 2(52)
- MDR Article 2(53)
- MDCG 2021-6 Q&A Dec23