EU IVDR Performance Evaluation Report (PER) Guide

What is an EU IVDR Performance Evaluation Report (PER)?

IVDs require a slightly different approach to general safety and performance requirements and performance evaluation assessment than medical devices. If an IVD fails to meet its intended performance for diagnosis, the risks can be very serious, though they may not materialize immediately. If an IVD fails to detect a potentially fatal infectious disease, for instance, delayed or inadequate treatment or even the spread of infection to others can be life threatening. The In Vitro Diagnostic Devices Regulation (EU IVDR 2017/746) imposes rigorous pre- and post-market performance evaluation requirements to control the risks associated with IVDs and ensure they consistently perform according to their intended purpose throughout their life cycle.

The IVDR defines performance evaluation as a “continuous process by which data are assessed and analysed to demonstrate the scientific validity, analytical performance and clinical performance of that device for its intended purpose.” A Performance Evaluation Report (PER) documents all of your performance evaluation activities, evidence, and conclusions and is part of your Technical Documentation (TD). Even after obtaining CE Marking, performance evaluation activities are ongoing and the PER should be continuously updated for as long as your device is on the market.

Performance evaluation requirements under the IVDR

Performance evaluation can be a complex activity, which is why it always starts with careful planning. Before you begin, you will need to write a Performance Evaluation Plan (PEP) that will be included within your TD. The PEP should describe the methods you will use during the PE process as well as justifications for those methods, detailed descriptions of your device, acceptance criteria related to the claimed intended purpose, intended use, patient populations and more. A detailed list of PEP requirements can be found in Annex XIII of the IVDR. The PE process is part of the Quality Management System requirements addressed in IVDR Article 10 (8) f).

Your PEP should specify how you will address the three elements of IVD performance: scientific validity, analytical performance, and clinical performance:

• Scientific validity should substantiate the relationship between your IVD’s analyte or marker and a clinical condition (e.g., the link between the SARS-CoV-2 virus and COVID-19 disease).

• Analytical performance demonstrates your device’s effectiveness at detecting its analyte or marker (e.g., the evidence that the subject device for diagnosis of a COVID-19 disease affecting the EU target population is able to detect the most current SARS-CoV-2 virus subtype in a defined human matrix).

• Clinical performance demonstrates the device’s ability to yield results correlated with a particular clinical condition or physiological/pathological process or state in the intended population. Clinical sensitivity/specificity and predictive values can be relevant. Cross-reactivity and interference are analytical-performance questions; usability is also assessed where applicable.

Clinical evidence includes the scientific validity, analytical performance, and clinical performance data to verify that your device conforms with the safety and performance requirements.

PER requirements and post-market performance evaluation

The PER presents the clinical evidence for your device, your assessment, and conclusions made by qualified clinical evaluators. It includes individual reports for scientific validity, analytical performance, and clinical performance data, as well as explanations of the methods you used to gather clinical evidence, perform literature searches, etc.

After your device is on the EU market, your PER will need to be updated continuously with new data and assessment conclusions from Post Market Surveillance and Post Market Performance Follow-up (PMPF) data.

Performance evidence mapped to the claim

Use MDCG 2022-2 with IVDR Annex XIII. Link the PER to PMPF, risk management and PMS, preserving favorable and unfavorable evidence.

Official framework and connected work

Use the current MDR, IVDR and Commission guidance for the applicable legal text and interpretation. Start from the EU market-entry hub for the overall pathway; this guide addresses the specific task within that program.

For regulatory terminology and the authority framework, see the EU MDR.