Performance Evaluation Report (PER) / Performance Evaluation Plan (PEP)

The report includes processing and appraisal of technical and clinical data from the scientific literature and data from the manufacturer concerning the safety of the product as well as its analytical and clinical performance. The methods applicable for the evaluation of the performance are laid down in the In Vitro Diagnostic Regulation (IVDR) and are specified in the guidelines developed by the Medical Device Coordination Group (MDCG). In general, specific analytical data need to be gathered by the manufacturer for every product which shall then be appraised in a report regarding the analytical performance as part of the PER. Evidence of the clinical performance, however, may also be derived from studies concerning equivalent diagnostic products. Furthermore, data from the literature regarding the medical background and well-established diagnostic standards (state of the art) as well as safety relevant data (e.g. from post-market surveillance of the diagnostic product or from websites and databases of competent authorities) may be used as evidence of the clinical performance. Already existing and marketed products may potentially need special attention in this regard. A careful integration of clinical data from the scientific literature and data from post-market surveillance regarding safety and performance may replace a clinical study, if necessary supported by already existing or newly compiled data from in vitro studies.