EU IVDR PER Performance Evaluation Report
A Performance Evaluation Report (PER) documents all of your performance evaluation activities, evidence, and conclusions.
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 how well the IVD performs in the hands of its intended user, such as a patient or layperson, clinician, etc. (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 and is not impacted by other respiratory viruses or medication or other interferences).
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.
Frequently
Asked Questions
How often should our Performance Evaluation Report be updated?
Performance evaluation is a continuous process and your PER should always be up to date. However, if your device is Class C or D, you must update your PER at least annually. PERs for Class A and B devices can be updated as needed.
What is a Clinical Performance Study Report?
Clinical performance studies, while not always required, are one potential source of data to demonstrate device performance. If you are conducting clinical performance studies, you must draft a clinical performance study plan that documents all aspects of your study design and methods, and then document the performance study protocol plan, results, and conclusions in your clinical performance study report.
What is Post-Market Performance Follow-up (PMPF)?
PMPF is a new requirement under the IVDR, in which the manufacturer must collect and evaluate performance and relevant scientific data from the use of a device to confirm the safety, performance, and scientific validity throughout the device’s life cycle. PMPF activities require documentation in a PMPF plan and PMPF report.
