Clinical Evidence & Performance Studies: IVDR

The IVDR (article 56 and Annex XIII) reinforces the need for clinical evidence to demonstrate conformity with the relevant general safety and performance requirements.

Performance evaluation of a device is a continuous process by which data are assessed and analyzed to demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended purpose as stated by the manufacturer. It should be based on a thorough and objective method and following a pre-established performance evaluation plan.

To correctly perform the evaluation, the manufacturer shall assess all relevant scientific validity, analytical and clinical performance data to verify the conformity of its device with the general safety and performance requirements. This will result in a qualified assessment, whose data and conclusions shall constitute the clinical evidence for the device, that is to say, the scientific proof that the intended clinical benefit(s) and safety will be achieved.

The clinical evidence shall be documented in a performance evaluation report  including the scientific validity report, the analytical performance report, the clinical performance report and an assessment of those reports allowing demonstration of the clinical evidence.

The  clinical evidence and its assessment in the performance evaluation report must be updated throughout the life cycle of the device concerned.