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IVDR Performance Evaluation Report
An IVDR performance evaluation report 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 bridge the gap between Annex XIII requirements and the latest MDCG frameworks thereby accurate and complete performance evaluation reports generated which in turn forms the Scientific Validity (MDCG 2022-2) to Legacy Transitions (MDCG 2022-6) engineered for total Notified Body alignment.
Achieving compliance under In Vitro Diagnostic Regulation (EU) 2017/746 requires more efforts and proper planning with substantial technical documentation with robust performance evaluation.
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What is an IVDR Performance Evaluation?
An IVDR performance evaluation means it is a continuous process for the collection, appraisal, analyse of a specific IVD device data to verify its scientific validity, analytical and clinical performance. From the earlier IVD Directive, compared with current IVD regulation it demands more structured, well arranged more authorative and data-driven concept.
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, the IVDR performance evaluation report must align with Annex XIII of the IVDR. A notified body convincing PER can be build on the below three strong points:
⇒ Provide Scientific Validity evidence in detail to demonstrate that the analyte is better associated with the intended clinical condition or physiological state.
⇒ Sensitivity, Specificity, Accuracy, and Limits of Detection, the so called Analytical Performance data demonstrating the device’s ability to correctly detect or measure a particular analyte must be sufficient enough to justify IFU claims.
⇒ Demonstrate clinically relevant correlation between the results generated by the device and the target clinical condition as per the intended user population.
Don’t let CE Marking delay your EU market entry. Contact us today for expert guidance on your IVDR PER 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 PER increases with the device risk class. For high risk Class C and class D devices the IVDR performance evaluation report requires extensive clinical evidence, often need a third party Clinical Research Organisations (CROs). I3CGlobal ensures that your IVDR performance evaluation strategy is acceptable to Guidelines and NB
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Our team develop a detailed Performance Evaluation Plan (PEP) before data collection begins.
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We ensure General Safety and Performance Requirements (GSPR) covers every claim in the report and maps directly to the appropriate records in the technical documentation
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Our team of expert regulatory consultants use in house methodology to reduce the technical documentation review comments and certification delay.
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 following are our main services
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Develop IVDR Performance Evaluation Plan (PEP) in consultation with manufacturer
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Writing the Scientific Validity, Analytical Performance, and Clinical Performance reports.
- Coordinate with third party Clinical Research Organization if necessary.
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Integrate 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
