Performance Evaluation Reports Under the IVDR

The performance evaluation report (PER) is the culmination of the application of the performance evaluation process to a specific IVD and is prepared under the performance evaluation plan (PEP).

Establishing a performance evaluation report under the IVDR

Section 1.3.2, Annex XIII of the IVDR establishes the content requirements of the performance evaluation report, the first of which is the justification for the approach taken to gather the clinical evidence. It is recommended that this justification be based on the following considerations:

• • • Intended purpose of the device, including intended users and use environment;
    • Degree of device novelty (e.g., novel test, established and non-standardized test, established and standardized test);
    • Nature, severity and evolution of the condition being diagnosed;
    • State of the art; and
    • If available, clinical experience data on the device that supports risk estimation and, in the case of ‘legacy devices’, PMS data that also supports such estimation.

Despite there not yet being any similar guidance for the IVDR, Appendix III of MDCG 2020-6 Clinical evidence needed for medical devices previously CE marked under Directives 93/42/EEC or 90/385/EEC also provides guidance that may be extrapolated to some extent to IVDs, as a means for manufacturers to define “appropriate” levels of clinical evidence for their devices. However, care should be taken with this approach.

The IVDR PER content requirements also make it clear that the following literature review information must be included in the performance evaluation report:

• • • Literature search methodology
    • Literature search protocol
    • Literature search report

For more detailed information on best practices for performance evaluation literature searches, refer to our previous article on this topic available here.

Aligning a performance evaluation report within a performance evaluation plan

The PER content on the device technology, intended purpose, and performance or safety claims should be aligned with the equivalent content of the performance evaluation report while in the case of performance or safety claims, in the PER the manufacturer will present and discuss the clinical evidence that supports these claims.

While Section 1.3.2, Annex XIII of the IVDR establishes the content requirements of the performance evaluation report, this report serves as a compilation of conclusions generated regarding several areas critical for the performance evaluation process, including data from:

• • • Scientific validity report (SVR)
    • Analytical performance report (APR)
    • Clinical performance report (CPR)
    • State of the art
    • Benefit-risk determination
    • Post-market performance follow-up (PMPF)

Where device performance includes characteristics that do not fall within the scope of analytical or clinical performance which demonstrate conformity with applicable GSPRs (e.g., electromagnetic compatibility and electrical safety testing), the PER serves as the most appropriate performance evaluation document to capture and consider such performance as these are critical to benefit-risk determination and state of the art assessments.

What should be discussed in a performance evaluation report?

As for state of the art, we’ve mentioned in previous articles that this should be included as a consideration when constructing literature searches (i.e., searches are performed for scientific validity, clinical performance (and safety), and state of the art). When assessing the data included from these literature searches and from the other data sources indicated above, manufacturers are recommended to consider and discuss the following in the performance evaluation report:

• • • Is the analyte state of the art for the specified condition?
    • Is the measuring range or test calculation (or other analytical and/or clinical performance characteristics) considered to be state of the art?
    • Is the device type or test recommended by clinical guidelines for the same intended purpose?
    • Does the device compare favorably with other devices on the market (particularly regarding benefit-risk determination)?
    • Does the device comply with the latest international standards (including harmonized standards and/or common specifications)?

The importance of updating your performance evaluation report

Lastly, the clinical evidence and its assessment in the PER must be updated throughout the device life cycle through the manufacturer’s PMPF plan as part of both performance evaluation and the manufacturer’s PMS system. Therefore, manufacturers should ensure that the PER includes a statement regarding the next scheduled update and mechanisms in place for unscheduled updates should the manufacturer become aware of clinical evidence that adversely impacts the conclusions of the PER, particularly regarding the benefit-risk determination, device claims, and conformity with applicable GSPRs.

Learn more about performance evaluation reports

• • • Planning Performance Evaluation Under the IVDR
    • Understanding the Specific Evaluation Documentation Required for IVD Performance Under Article 56 of the IVDR
    • Navigating IVDR Compliance: Applicability of Scientific Validity for IVDs

Contact MedEnvoy

If you have any additional questions regarding performance evaluation or require relevant training / consulting services, get in touch.