Special features of the clinical evaluation of stand-alone software
According to classification rule 11 EU-MDR, individual software (eg recognizable by the restriction to (possibly graphic GUI) user-product-interface / product-product- (data-) interface) hardly ever falls into class I, the most software, namely diagnostic or therapeutic decision making software, is at least class IIa or higher. From class IIa, a Notified Body is to be involved.
Clinical Equipoise, established at the Clinical Assessment Office, Prof. Zenner, allows us to answer the final question of the acceptability of the benefit / risk ratio of stand-alone software, taking into account the patient's well-being.
The clinical evaluation of individual software verifies that the software provides the promised benefits.
1. In simple cases, performance data and verification results may be sufficient.
2. For algorithms, such as scoring, clinical evaluation using literature data may prove that the algorithm has been clinically validated.
3. However, if the algorithms are more complex, it may be necessary to have clinical proof of clinical benefit.