A Performance Evaluation Report (PER) is a comprehensive clinical document that demonstrates the safety and performance of In Vitro Diagnostic (IVD) devices. It is mandatory for manufacturers to submit this document to place their IVDs in the European Union (EU) market. The PER is built on the foundation of the following three (03) pillars of data demonstration:
- Scientific Validity Report (SVR)
- Analytical Performance Report (APR)
- Clinical Performance Report (CPR)
The PER is submitted to the Notified Bodies (NBs) for the conformity assessment procedure, based on which the IVDs receive the Declaration of Conformity (DoC) and Conformité Européenne (CE) marking approval. Article 56 and Annex XIII of the EU IVD Regulations (IVDR) 2017/746 lay out in details the requirements for the PER. However, understanding a PER can be challenging. Thus, in this article, we will look at a synopsis of the overall performance evaluation process of IVD devices. The steps involved in the process are as follows:
- Designing the PEP: The very first step is to design a Performance Evaluation Plan (PEP), which is an outline of the performance evaluation process that leads to the PER. It involves the identification of the systems and processes required to generate clinical evidence based on aspects like performance characteristics, innovation and/or novelty of the devices, intended use, etc.
- Data Collection and Establishment: This step involves identifying and evaluating the available data in accordance with the General Safety and Performance Requirements (GSPR), under Annex I of the EU IVDR 2017/746. It also includes identifying if any additional support is required or if any gap exists with respect to data demonstration for SVR, APR, and CPR.
A thorough literature search via robust databases like PubMed, Cochrane Library, etc., is required, along with a robust strategy. Moreover, support from additional clinical data such as clinical experience, clinical trials, internal data (meeting excerpts, ongoing clinical studies, etc.), and Post-marketing Surveillance (PMS) data can supplement the report. The clinical data should be set based on the currently acknowledged state-of-the-art practice.
- Data Analysis and Interpretation: The data collected is analyzed in terms of its safety (for instance, misdiagnosis) and performance characteristics (for instance, sensitivity, accuracy, trueness, precision, reproducibility, etc.). Following this, the data is interpreted to verify the clinical significance of the device’s performance characteristics. It is often demonstrated via comparative analyses with the performance characteristics of other devices in the market or with the established standards. The data should be quantitative enough to address the claims set for the IVD and detect any gaps that might trigger a Post-market Performance Follow-up (PMPF).
- Preparation of the PER: Based on the data collected, establishment, analysis, interpretations assessments, and conclusions are documented in the PER. In the case of Class C and D IVDs, a summary of safety and performance is also drawn up alongside the PER.
- Submitting and Updating the PER: The completed PER should be submitted to the respective Notified Body (NB) responsible for the conformity assessment of the device.
Additionally, the PER should be updated throughout the lifecycle of the device as new data becomes available. Manufacturers must establish a PMS system to monitor the performance of their devices and to report any adverse events to the competent authorities.
Compliance with the EU IVDR and the preparation of a comprehensive PER is crucial for manufacturers seeking to market their IVD devices in the EU. The preparation of the PER is a complex and time-consuming process that requires significant expertise in clinical research, statistics, and Regulatory Affairs (RA).
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