To CE-mark a medical device the manufacturer needs to provide clinical evidence of safety and performance. Clinical evidence is needed for all medical devices, irrespective of device class or legislation (MDR or IVDR).
The manufacturer must regularly, during the whole life-cycle of the device, evaluate whether there is still sufficient clinical evidence to support that the device can be safely used and regarded as state-of-the-art technology. A fundamental initial step is to form a well thought through and adequate clinical strategy to drive the whole process forward.
Clinical evidence for a medical device is normally based on clinical data, i.e. results from the clinical use of the device or an equivalent device. Clinical data are summarised and analysed in the clinical evaluation.
For IVD-devices, clinical evidence also includes the results of the performance evaluation, including scientific validity, analytical performance and clinical performance.
QAdvis expert consultants can:
Develop an over-all clinical strategy
Identify any gaps in clinical data aiming at demonstration of clinical evidence for a device
Perform clinical evaluations according to the MDR and the MDD
Contribute to performance evaluation documentation according to the IVDR and the IVDD, including planning of clinical performance studies
Perform literature reviews to form part of clinical evaluation / performance evaluation