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Mastering the IVDR Performance Evaluation Report (PER)
In the evolving landscape of European regulations, achieving compliance under In Vitro Diagnostic Regulation (EU) 2017/746 requires more than just technical documentation, it requires a robust performance evaluation.
An IVDR performance evaluation report (PER) is the cornerstone of your technical file. It serves as the primary evidence to demonstrate that your device achieves its intended purpose and maintains a high level of safety and efficacy and also it validates the clinical evidence for your product throughout its lifecycle. At I3CGLOBAL, our regulatory experts meticulously bridge the gap between Annex XIII requirements and the latest MDCG frameworks, architecting performance evaluation reports where every pillar from Scientific Validity (MDCG 2022-2) to Legacy Transitions (MDCG 2022-6) is engineered for total Notified Body alignment.
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What is an IVDR Performance Evaluation?
An IVDR performance evaluation is a continuous process of collecting, appraising, and analyzing data to verify the scientific validity, analytical performance, and clinical performance of an IVD device. Unlike the previous IVDD, the current regulation demands a much more structured and data-driven approach.
The results of this ongoing process are documented in the IVD performance evaluation report, which must be regularly updated throughout the product’s lifecycle as part of your Post-Market Performance Follow-up (PMPF)
Key Components of a Compliant IVDR Performance Evaluation Report
To ensure a smooth certification process, your IVDR performance evaluation report must align with Annex XIII of the IVDR. A high-quality report is built upon three essential pillars:
⇒ Scientific Validity: Evidence that the analyte or marker is truly associated with the intended clinical condition or physiological state.
⇒ Analytical Performance: Data demonstrating the device’s ability to correctly detect or measure a particular analyte (including sensitivity, specificity, accuracy, and limits of detection).
⇒ Clinical Performance: Documentation proving that the device yields results that are correlated with the target clinical condition in the intended user population.
Don’t let regulatory hurdles delay your market entry. Contact us today for expert guidance on your IVDR performance evaluation and technical documentation.
Why Technical File needs a Professional IVD Performance Evaluation Report
Whether you are manufacturing Class A, B, C, or D devices, a performance evaluation report is mandatory. However, the complexity of these reports increases with the risk class of the device. For high-risk IVDs (Class C and D), the IVDR performance evaluation report requires extensive clinical evidence, often necessitating collaboration with Clinical Research Organisations (CROs). Our team ensures that your IVD performance evaluation strategy is:
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Our team methodically planned and develop a detailed Performance Evaluation Plan (PEP) before data collection begins.
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We ensure GSPR Aligned and every claim in your report maps directly to the General Safety and Performance Requirements (GSPR).
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We use industry best practices to minimize the risk of technical documentation file rejection by Notified Body
The I3CGlobal Team Advantage: Expert IVDR Performance Evaluation Services
Navigating the shift from IVDD to IVDR can be challenging. Our seasoned consultants provide end-to-end support for your IVDR performance evaluation report needs. From literature searches and state-of-the-art analysis to the final compilation of the PER, we provide the technical expertise required to get your products to market faster. The core services are the following
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Developing the IVDR Performance Evaluation Plan (PEP).
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Writing the Scientific Validity, Analytical Performance, and Clinical Performance reports.
- Coordinating with Third Part CRO’s and CMO’s for studies during planning and through out studies and NB review
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Integrating the IVD performance evaluation report into your Quality Management System (QMS).
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Gap analysis of existing data to meet new IVDR standards.
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Frequently Asked Questions
Is performance Evaluation being a continues process?
Yes, the process of performance evaluation is designed to be continuous, involving the gathering of clinical evidence throughout the lifespan of the product. This is achieved with the assistance of the post-market performance follow-up process
Very useful for small and medium size medical device manufactures
