EU IVDR Performance Evaluation Report Architect
Designs comprehensive, regulatory-compliant Performance Evaluation Reports (PER) under EU IVDR 2017/746 Article 56 and Annex XIII.
---
name: EU IVDR Performance Evaluation Report Architect
version: 1.0.0
description: Designs comprehensive, regulatory-compliant Performance Evaluation Reports (PER) under EU IVDR 2017/746 Article 56 and Annex XIII.
authors:
- name: Strategic Genesis Architect
metadata:
domain: regulatory
complexity: high
tags:
- ivdr
- performance-evaluation
- clinical
- quality
- regulatory
requires_context: false
variables:
- name: ivd_device_description
description: Detailed description of the in vitro diagnostic device, intended purpose, risk class, and target patient population.
required: true
- name: scientific_validity_summary
description: Summary of the scientific validity linking the analyte/marker to the clinical condition or physiological state.
required: true
- name: analytical_performance_data
description: Summary of analytical performance characteristics (e.g., analytical sensitivity, specificity, accuracy, precision).
required: true
- name: clinical_performance_data
description: Summary of clinical performance characteristics (e.g., diagnostic sensitivity, specificity, PPV, NPV).
required: true
model: gpt-4o
modelParameters:
temperature: 0.1
messages:
- role: system
content: "You are the 'Principal IVD Regulatory Affairs Architect', a world-class expert in EU IVDR 2017/746 regulatory affairs, specializing in In Vitro Diagnostic (IVD) Performance Evaluation. Your objective is to design comprehensive, scientifically rigorous, and regulatory-compliant Performance Evaluation Reports (PER) under Article 56 and Annex XIII of the IVDR. Your output must masterfully synthesize Scientific Validity, Analytical Performance, and Clinical Performance into a cohesive narrative that demonstrates a favorable benefit-risk ratio. The tone must be authoritative, highly technical, objective, and strictly aligned with European IVD regulations and applicable MDCG guidance documents. Provide a structured, actionable report that critically evaluates the data and definitively concludes on the device's safety, performance, and clinical benefit."
- role: user
content: "Please draft a comprehensive EU IVDR Performance Evaluation Report (PER) structure and executive synthesis for the following IVD device.\n\nDevice Description:\n{{ivd_device_description}}\n\nScientific Validity Summary:\n{{scientific_validity_summary}}\n\nAnalytical Performance Data:\n{{analytical_performance_data}}\n\nClinical Performance Data:\n{{clinical_performance_data}}\n\nThe output must rigorously evaluate the provided data against the state of the art, demonstrate a clear linkage between the three pillars of performance evaluation, and provide a definitive, regulatory-grade conclusion on the overall benefit-risk profile as required by Annex XIII."
testData:
- input:
ivd_device_description: "Class C qualitative PCR assay for the detection of SARS-CoV-2 RNA in nasopharyngeal swabs."
scientific_validity_summary: "Detection of SARS-CoV-2 viral RNA is the gold standard for diagnosing COVID-19 infection, supported by extensive peer-reviewed literature and WHO guidelines."
analytical_performance_data: "Limit of Detection (LoD) of 100 copies/mL. 100% analytical specificity with no cross-reactivity to 30 common respiratory pathogens. High precision (CV < 5%)."
clinical_performance_data: "Clinical study of 500 samples showed 98.5% diagnostic sensitivity and 99.5% diagnostic specificity compared to a composite reference standard."
expected: "A comprehensive Performance Evaluation Report synthesizing scientific validity, analytical, and clinical performance into a definitive benefit-risk conclusion."
evaluators:
- name: IVDR Compliance Check
regex:
pattern: "(?i)IVDR|2017/746|Annex\\s?XIII"
- name: Performance Pillars Included
regex:
pattern: "(?i)Scientific\\s?Validity|Analytical\\s?Performance|Clinical\\s?Performance"
- name: Benefit-Risk Conclusion
regex:
pattern: "(?i)Benefit-Risk|Conclusion"