Clinical Performance Report (CPR) Overview
The IVDR (2017/746) has brought about a significant shift in performance evaluation, introducing heightened stringency and demands. Annex XIII part A outlines a three-step performance evaluation process encompassing Scientific Validity, Analytical Performance, and Clinical Performance reports, all integral to the premarket assessment as well as an assessment of lifecycle management of the device.
Defined in Article 2 of IVDR 2017/746, Clinical Performance refers to a device's capacity to produce results that align with specific clinical conditions, physiological or pathological processes, and the intended user and target population. Following the demonstration of Analytical Performance, manufacturers are now tasked with planning Clinical Performance studies. These studies aim to validate and establish facets of the IVD medical device that cannot be adequately covered by analytical performance data, existing literature, or routine diagnostic testing experiences. This shift underscores the importance of comprehensively understanding a device's performance within real-world clinical scenarios.
Clinical Performance Report (CPR) Outline in IVDR Performance Evaluation Report (PER)
As per the EU IVDR 2017/746 guidelines, an essential requirement is the inclusion of the Clinical Performance Report (CPR) within the Performance Evaluation Report (PER) for all in vitro diagnostic devices (IVDs) aiming to enter the European market. This comprehensive report assesses the IVD's clinical performance, covering crucial aspects such as design, intended use, target users, analytical performance, and most importantly, the clinical performance. The integration of the Clinical Performance Report within the PER is a crucial step to ensure the device's safety and effectiveness for its intended purpose within the specific user group, while ensuring compliance with the EU IVDR's stringent requirements.
- Analysis and Conclusions
Annex XIII states that demonstration of the clinical performance of a device should be based on one, or a combination of the following sources:
- Clinical performance studies
- Scientific peer-reviewed literature
- Published experience gained by routine diagnostic testing (as stated in Annex XIII).
Clinical performance of the IVDs can be demonstrated by various applicable aspects such as diagnostic sensitivity, specificity, usability, user interface, odds ratio, positive likelihood ratio, intended use environment(s), etc. It is crucial to evaluate aspects of clinical performance with statistical significance, including the incorporation of confidence intervals and an assessment of how the results impact the reliability of the intended purpose.
The CPR is derived basis the clinical performance studies carried out in accordance with the Annex XIII EU IVDR 2017/746. Article 2 of EU IVDR 2017/746 defines clinical performance studies as “Clinical Performance is defined as: “the ability of a device to yield results that are correlated with a particular clinical condition, a physiological or pathological process, or in accordance with the target population and intended user.”
With over decade of experience and a dedicated team of subject matter experts, Freyr has built a robust model to deliver quality CPRs of complex products.
- Transition plan for IVDR compliance.
- Scientific validity reports based on literature and/or in-house data.
- Clinical performance reports based on literature and/or in-house data.
- Analytical Performance Reports.
- Clinical Evidence for Performance Evaluation Reports as per IVDR.
- Performance Evaluation Plan.
- Post Market Performance Follow Up (PMPF) protocols and reports.
- Post Market Surveillance (PMSR) protocols and reports.
- Writing/Revising other documents, such as package insert/IFU, Quick Reference Instructions (QRI), operation/user manual, etc.
- Assured compliance with recent applicable regulations.
- Team of qualified experts.
- Tailored Solutions to your requirements
- Regulatory Resource Management/Staff Augmentation Services
- Cross-functional inputs from Medical Device experts to comply with requirements.