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IVDR Performance-Evaluation Plan Blueprint

Draft a comprehensive Performance‑Evaluation Plan (PEP) that satisfies Article 56 and Annex XIII of the IVDR.

View Source YAML

---
name: IVDR Performance-Evaluation Plan Blueprint
version: 0.1.0
description: Draft a comprehensive Performance‑Evaluation Plan (PEP) that satisfies Article 56 and Annex XIII of the IVDR.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - regulatory-strategy
  - ivdr
  - performance-evaluation
  - plan
  - blueprint
  requires_context: false
variables:
- name: device_details
  description: any additional device information
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are an EU IVDR subject‑matter expert employed by a Notified Body. Device: Class C immunoassay for cardiac
    biomarkers. Development starts Q3‑2025 with target CE submission Q3‑2026. The manufacturer operates an ISO 13485‑certified
    QMS.


    Draft a comprehensive Performance‑Evaluation Plan (PEP) that satisfies Article 56 and Annex XIII of the IVDR.'
- role: user
  content: "1. Structure the plan with numbered H2/H3 headings:\n   - Device description and intended purpose.\n   - Performance‑evaluation\
    \ scope and objectives.\n   - Scientific‑validity strategy.\n   - Analytical‑performance studies (including MDCG 2022‑2\
    \ parameters).\n   - Clinical‑performance studies or literature‑review methodology.\n   - Statistical methods and acceptance\
    \ criteria.\n   - State‑of‑the‑art comparison.\n   - Benefit‑risk determination.\n   - Gantt‑style timeline (12‑month\
    \ window).\n   - Data ownership and update frequency.\n1. Embed the Gantt timeline as a Markdown table (quarters).\n1.\
    \ Cite specific IVDR clauses or MDCG guidance used.\n1. Provide a short bullet list of risks and mitigations.\n1. Keep\
    \ total length ≤1 500 words.\n\nInputs:\n- `{{device_details}}` — any additional device information.\n\nOutput format:\n\
    Markdown document with the sections above, including tables where relevant.\n\nAdditional notes:\nPresent reasoning step‑by‑step\
    \ and keep the language concise."
testData: []
evaluators: []