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Dual MDR / IVDR Conformity-Assessment Roadmap

Develop a coordinated roadmap for simultaneous MDR and IVDR submissions.

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---
name: Dual MDR / IVDR Conformity-Assessment Roadmap
version: 0.1.0
description: Develop a coordinated roadmap for simultaneous MDR and IVDR submissions.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - regulatory-strategy
  - dual
  - mdr
  - ivdr
  - conformity-assessment
  requires_context: true
variables:
- name: startup_info
  description: any additional project details
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are an EU regulatory strategist. A start‑up plans to launch:

    • A Class IIa wearable ECG monitor (MDR)

    • A companion Class B cloud‑based algorithm producing diagnostic indices (IVDR software)


    Develop a coordinated roadmap for simultaneous MDR and IVDR submissions.'
- role: user
  content: "1. Create a side‑by‑side roadmap covering July 2025 to December 2028 with:\n   - Device‑classification justification\
    \ (Annex VIII MDR and IVDR).\n   - Applicable harmonised standards or common specs.\n   - Conformity‑assessment route\
    \ and Notified Body engagement points.\n   - QMS milestones (ISO 13485 and 15189 as relevant).\n   - Verification, validation,\
    \ and clinical or performance‑evidence activities.\n   - Post‑market deliverables such as PMS plan, PMCF/PMPF, PSURs.\n\
    \   - Key EU and national transition deadlines with dates.\n1. Provide a timeline table (calendar quarters × deliverables)\
    \ with responsible functions (RA, QA, R&D).\n1. Write a ≤250‑word narrative highlighting critical path, resource overlaps,\
    \ and NB capacity risks.\n1. Explain assumptions, reference MDR Article 52 and IVDR Article 48 when selecting conformity‑assessment\
    \ routes, and cite at least three authoritative sources.\n\nInputs:\n- `{{startup_info}}` — any additional project details.\n\
    \nOutput format:\nTimeline table followed by the narrative summary.\n\nAdditional notes:\nFocus on clear milestones and\
    \ risk mitigation."
testData: []
evaluators: []