,Performance Evaluation of In Vitro Diagnostic (IVD) Devices Overview
Freyr delivers end-to-end performance evaluation solutions tailored for In Vitro Diagnostic (IVD) devices, helping manufacturers achieve both Regulatory compliance and peak product performance. Under the EU IVDR, performance evaluation requires robust evidence across three pillars: Scientific Validity, Analytical Performance, and Clinical Performance. Freyr strengthens each of these pillars through structured documentation, targeted literature analysis, and comprehensive evidence synthesis, ensuring your device meets evolving IVDR expectations with confidence and clarity.
Freyr’s Performance Evaluation Tailored Services
Performance Evaluation Gap Analysis
Freyr’s experts perform detailed gap analyses across IVD performance and clinical documentation to ensure evidence is complete, reliable, and regulatory-ready. This guarantees strong alignment with regulatory expectations and global medical device performance evaluation requirements.
Tailored Literature Strategy Preparation
Freyr develops customized literature search and review strategies aligned with the device’s intended purpose. These strategies support PMPF, Clinical Performance Reports, SOTA assessments, and broader performance evaluation in IVDR evidence requirements.
Subject Matter Expert (SME) Support for Non-Conformities Review
Freyr's SMEs provide objective review of non-conformities across clinical and performance documentation to ensure consistency with IVDR performance evaluation expectations.
SOP Writing
Freyr’s SOP writing services develops robust, IVDR-aligned standardised procedures for performance evaluation activities, enhancing traceability and supporting consistent performance evaluation under IVDR.
Life Cycle Management of Clinical Reports
Freyr provides annual maintenance services for Performance Evaluation Reports (PER), Clinical Performance Reports (CPR), Scientific Validity Reports (SVR), and Analytical Performance Reports (APR). This ensures documentation stays current and reflective of emerging evidence, supporting ongoing IVD performance evaluation obligations.
Full-Time Employee Support
Freyr provides dedicated resources to support performance evaluation activities, ensuring continuity across ongoing IVDR performance evaluation requirements.
Procedural Trainings
Freyr offers procedural training sessions on performance evaluation methods, IVDR-compliant documentation, literature evaluation, and analytical and clinical evidence expectations empowering teams to meet EU IVDR performance evaluation standards.
Freyr’s Performance Evaluation Services
Freyr’s Performance Evaluation End-To-End Services
Freyr assists in creating a robust Performance Evaluation Plan (PEP) tailored to IVD specific requirements, ensuring Regulatory compliance and optimal evaluation outcomes. Under the EU IVDR, the PEP defines the methodology, evidence sources, acceptance criteria, and lifecycle approach needed to demonstrate conformity with Annex XIII. Freyr’s structured approach helps ensure every element of the performance evaluation is well-designed, comprehensive, and aligned with current regulatory expectations.
Freyr compiles a Performance Evaluation Report (PER) in accordance with the requirements of the In Vitro Diagnostic Regulation (IVDR), ensuring thorough documentation of IVD performance data. The Performance Evaluation Report consolidates evidence from SVR, APR, CPR, and PMPF activities into a unified, traceable record of performance. A compliant IVDR Performance Evaluation Report is maintained throughout the device lifecycle.
Freyr's Scientific Validity Reports (SVR) provide an in-depth analysis of the scientific validity of IVD performance claims, along with a thorough analysis of the currently available guidelines. A Scientific Validity Report establishes the association between the analyte and the clinical condition, forming the foundation for analytical and clinical performance assessments.
The team at Freyr prepares Clinical Performance Reports (CPR), providing a comprehensive overview of IVDs' clinical performance based on rigorous and structured literature analysis. This clinical performance evaluation approach documents clinical sensitivity, specificity, predictive values, and real-world performance insights ensuring strong and compliant performance documentation under the EU IVDR
Freyr compiles Analytical Performance Reports (APR), ensuring comprehensive documentation of IVDs’ analytical performance characteristics. Our team meticulously analyzes precision, accuracy, sensitivity, specificity, and detection parameters to provide clear, reliable, and IVDR-aligned analytical performance evidence. with Analytical Performance Report expectations.
- For Immunohistochemistry (IHC) assays, Freyr offers documentation support for NordiQC-based sample reports.
- Freyr also prepares Trueness Reports to assess the accuracy and reliability of IVD measurements, strengthening overall IVD performance evaluation requirements.
Freyr offers specialized services for drafting Summaries of Safety and Performance (SSP) for Class C and D devices, ensuring clarity for users and alignment with IVDR requirements
Frequently Asked Questions (FAQs)
1)What are the core components of performance evaluation under EU IVDR?
Performance evaluation under EU IVDR is built on three core components: scientific validity, analytical performance, and clinical performance. Together, these elements provide evidence that an IVD measures what it claims to measure, performs reliably under defined conditions, and produces clinically meaningful outcomes. IVDR requires these components to be continuously assessed throughout the device’s lifecycle.
2)How does scientific validity influence the overall performance evaluation process?
Scientific validity establishes the association between an analyte and a clinical condition, forming the foundation for all subsequent performance studies. IVDR requires manufacturers to demonstrate this association through systematic literature evaluation and established scientific principles, ensuring analytical and clinical evidence is generated within a scientifically credible framework.
3)Why is analytical performance evidence important for IVDR compliance?
Analytical performance evidence demonstrates how reliably an IVD measures its intended analyte under defined laboratory conditions. Parameters such as precision, accuracy, specificity, and detection limits confirm technical robustness. Under IVDR, analytical validation links scientific validity to real-world measurement reliability, ensuring performance claims are technically sound before clinical evaluation begins.
4)What distinguishes clinical performance evaluation from analytical studies under IVDR?
Clinical performance evaluation focuses on how an IVD performs in its intended clinical environment using metrics such as clinical sensitivity, specificity, and predictive values. Unlike analytical studies, which assess technical parameters such as accuracy, precision, analytical sensitivity, analytical specificity, clinical evaluation examines whether device results support meaningful clinical decision-making for the intended patient population. IVDR requires both evidence streams for comprehensive performance assessment.
5)How does IVDR change the expectations for ongoing performance evaluation compared to IVDD?
IVDR introduces a lifecycle-based approach to performance evaluation, requiring continuous reassessment and integration of new evidence rather than one-time submissions. Updated literature, analytical data, clinical insights, and PMPF findings must be incorporated regularly, ensuring real-world relevance, scientific accuracy, and ongoing reliability across evolving healthcare contexts.
6)Why is literature evaluation essential in establishing State-of-the-Art for IVDs?
Literature evaluation defines the State-of-the-Art by identifying current scientific understanding, clinical practices, reference methods, and benchmark performance levels. Under IVDR, SOTA is essential for contextualizing device claims, determining acceptance criteria, validating performance expectations, and supporting both scientific validity and PMPF planning.
7)What role does PMPF play in the performance evaluation lifecycle under IVDR?
Post-Market Performance Follow-up (PMPF) enables ongoing verification of device performance using real-world data after market entry. PMPF helps detect emerging risks, confirm analytical and clinical stability, and update the Performance Evaluation Report over time. This requirement under IVDR ensures continuous evidence generation and lifecycle-based performance oversight.
8)How should manufacturers approach updating performance evaluation documentation under IVDR?
Manufacturers should treat performance evaluation documentation as living records that evolve with new scientific, analytical, clinical, and PMPF evidence. IVDR expects ongoing reassessment to maintain alignment with changing scientific knowledge, clinical practice, and real-world performance, ensuring the Performance Evaluation Report remains current and reflective of device behavior over time.
9)Why is Freyr considered a leading partner for performance evaluation services?
Freyr is recognized as a leading partner for performance evaluation because of its comprehensive understanding of IVDR evidence requirements, structured approach to scientific validity, analytical performance, and clinical performance, and its emphasis on traceability, documentation rigor, and lifecycle maintenance. This combination supports manufacturers in meeting complex regulatory expectations with clarity, consistency, and methodological precision.
