Clinical evidence vs. clinical benefit
Clinical evidence is required for each IVD product regardless of the product class. It also allows a qualified assessment of whether the device is safe and achieves the intended clinical benefit(s), when used as intended by the manufacturer. Clinical evidence is collected in a continuous process of performance evaluation during the entire product life cycle. In the pre-market-phase it is collected during scientific validity evaluation. It is also collected during performance evaluation within analytical and clinical performance studies. These follow a performance evaluation plan. In the post-market-phase performance data is collected in PMPF-studies. This is done to confirm the clinical evidence after market approval following a PMS plan.
Clinical benefit is a term describing the positive impact of an IVD related to its function (e.g. screening, monitoring, diagnosis or aid in diagnosis of patients), on patient management or public health.
