Performance Evaluation Report (PER) / Performance Evaluation Plan (PEP)
Manufacturers of in vitro diagnostics are required to evaluate performance and safety of their products and validate the diagnostic performance as part of the technical documentation. For this purpose, the diagnostic performance and sensitivity of the product need to be tested in an analytical, and usually also a clinical study, which are documented in a Performance Evaluation Report (PER). This report needs to be updated continually.
The regulatory demands for diagnostic products have increased significantly since Regulation (EU) 2017/746 (In Vitro Diagnostic Regulation, IVDR) became generally applicable on 26 May 2022. This creates new challenges for the manufacturers, especially if the diagnostic products are already on the market.
Evaluation report for the performance of in vitro diagnostics
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.
The Performance Evaluation Report for in vitro diagnostics (IVDs) is composed of three parts:
- The scientific background of the diagnostic method including the reasoning for choosing that specific method and its scientific validity
- Validation of the analytical performance of the diagnostic product
- Validation of the clinical performance of the diagnostic product
Based on the data of the PER, a benefit-risk analysis needs to be established which demonstrates the acceptability of all risks compared to the benefits. The risks and hazards that may be posed by the use of the product (for the patient, but also for the user) need to be evaluated in a hazard analysis. Subsequently, conformity with all relevant General Safety and Performance Requirements (GSPRs), as specified in Annex I of the IVDR, must be demonstrated.
Dr. Ebeling & Assoc. GmbH will be happy to support you in the preparation of the Performance Evaluation Report according to the current IVDR and the MDCG guidances for a successful validation by your Notified Body.