Analytical Performance Report (APR) Overview
The Analytical Performance Report (APR) serves as a vital link in the chain of performance evaluation for medical devices. It encapsulates crucial data and insights that contribute to the assessment of a device's accuracy, precision, and overall reliability. By consolidating trueness, sensitivity, and specificity values, the APR provides a comprehensive snapshot of a device's analytical prowess.
Analytical Performance Report (APR) in IVDR Performance Evaluation
- Analysis and Conclusions
Where a performance evaluation involves a meticulous analysis of how a device functions under various conditions and scenarios. The APR enriches this evaluation process by offering a detailed examination of a device's ability to produce accurate results and its sensitivity to detecting positive cases while minimizing false positives.
In the dynamic landscape of medical device development, an Analytical Performance Report (APR) emerges as a cornerstone, translating precision and compliance into tangible benefits. Rooted in the European Union In Vitro Diagnostic Regulation (EU IVDR), an APR encapsulates trueness, sensitivity, and specificity values—key determinants of a diagnostic device's reliability and clinical relevance.
Key Elements of an Analytical Performance Report (APR) as per EU IVDR 2017/746
At Freyr, we specialize in empowering manufacturers to draft comprehensive APR studies in alignment with EU IVDR mandates. Our expertise extends to deriving trueness, sensitivity, and specificity values from existing studies, enabling your device to excel in performance and regulatory compliance.
Benefits of Partnering with Freyr
Regulatory Navigators: Our team is well-versed in EU IVDR requirements. We guide you through the intricate pathways of APR creation, ensuring each element aligns with regulatory expectations.
Data Synthesis Masters: Leveraging our expertise, we meticulously synthesize existing studies to extract trueness, sensitivity, and specificity values, forming the bedrock of your APR.
Accurate Performance Evaluation: We go beyond data extraction, engaging in rigorous analysis to derive meaningful performance metrics that underscore your device's reliability.
Streamlined Compliance: By partnering with us, you navigate the complex EU IVDR landscape seamlessly, avoiding pitfalls and delays in compliance attainment.
Enhanced Market Presence: An APR fortified by our expertise positions your device as a beacon of accuracy, resonating with healthcare professionals and regulators alike.
Broad Therapeutic Area Expertise: Our therapeutic proficiency spans a vast spectrum, enhancing the precision and relevance of your APR. By integrating therapeutic insights, we ensure that your device's performance evaluation aligns seamlessly with real-world clinical scenarios, bolstering its clinical utility and impact.
Analytical Performance Report
- Transition plan for IVDR compliance.
- Scientific Validity Report (SVR) based on literature and/or in-house data.
- Clinical Performance Reports (CPR) based on literature and/or in-house data.
- Analytical Performance Reports (APR).
- Clinical Evidence or 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.
