IVD Performance Study Compliance Review

Review an IVD performance study for compliance with MDCG 2024‑4 and related guidance.

View Source YAML

---
name: IVD Performance Study Compliance Review
version: 0.1.0
description: Review an IVD performance study for compliance with MDCG 2024‑4 and related guidance.
metadata:
  domain: regulatory
  complexity: medium
  tags:
  - regulatory-strategy
  - ivd
  - performance
  - study
  - compliance
  requires_context: true
variables:
- name: study_overview
  description: summary of the performance study design
  required: true
model: gpt-4o-mini
modelParameters:
  temperature: 0.2
messages:
- role: system
  content: 'You are advising on an EU IVDR performance study. The user needs guidance on adverse‑event reporting, summary
    forms, and risk mitigation, plus alignment with Swissmedic and UK requirements.


    Review an IVD performance study for compliance with MDCG 2024‑4 and related guidance.'
- role: user
  content: '1. Walk through MDCG 2024‑4 compliance steps for the study.

    1. Detail adverse‑event and event‑reporting procedures and required summary forms.

    1. Recommend risk‑mitigation strategies.

    1. Advise on harmonizing with Swissmedic and UK guidance.


    Inputs:

    - `{{study_overview}}` — summary of the performance study design.


    Output format:

    Bulleted guidance followed by a short summary paragraph.


    Additional notes:

    Use clear references to MDCG 2024‑4 and related authorities.'
testData: []
evaluators: []