🛠️ Mason: Add MDR and Vigilance Decision Evaluator prompt

docs/index.md

@@ -493,6 +493,7 @@ Whether you are a Product Manager, Clinical Lead, or Software Engineer, this rep
 - [Integrated Submission Strategy Coach](prompts/regulatory/quality/integrated_submission_strategy_coach.prompt.md)
 - [ISO 10993 Biological Evaluation Plan Architect](prompts/regulatory/quality/iso_10993_biological_evaluation_plan_architect.prompt.md)
 - [Medical Device Recall Strategy Architect](prompts/regulatory/quality/medical_device_recall_strategy_architect.prompt.md)
+- [Medical Device Reporting (MDR) and Vigilance Decision Evaluator](prompts/regulatory/quality/medical_device_reporting_decision_evaluator.prompt.md)
 - [Part 11 Closed System Audit](prompts/regulatory/quality/part_11_closed_system_audit.prompt.md)
 - [Quality-Improvement RCA & Action Plan](prompts/regulatory/quality/quality_improvement_rca_action_plan.prompt.md)
 - [Quality System Audit](prompts/regulatory/quality/quality_system_audit.prompt.md)

docs/prompts/regulatory/quality/medical_device_reporting_decision_evaluator.prompt.md

@@ -0,0 +1,102 @@
+---
+title: Medical Device Reporting (MDR) and Vigilance Decision Evaluator
+---
+
+# Medical Device Reporting (MDR) and Vigilance Decision Evaluator
+
+Evaluates post-market complaints and adverse events to determine reportability to regulatory authorities under FDA 21 CFR 803 and EU MDR 2017/745 Article 87.
+
+[View Source YAML](https://github.com/fderuiter/proompts/blob/main/prompts/regulatory/quality/medical_device_reporting_decision_evaluator.prompt.yaml)
+
+```yaml
+---
+name: Medical Device Reporting (MDR) and Vigilance Decision Evaluator
+version: 1.0.0
+description: Evaluates post-market complaints and adverse events to determine reportability to regulatory authorities under FDA 21 CFR 803 and EU MDR 2017/745 Article 87.
+authors:
+  - Strategic Genesis Architect
+metadata:
+  domain: regulatory/quality
+  complexity: high
+  tags:
+    - quality
+    - vigilance
+    - mdr
+    - fda
+    - eu-mdr
+    - complaints
+    - "21-cfr-803"
+variables:
+  - name: complaint_description
+    description: Detailed description of the event or issue reported by the user, patient, or healthcare professional.
+  - name: patient_impact
+    description: Information regarding any injury, harm, or medical intervention required as a result of the event.
+  - name: device_malfunction
+    description: Details on whether the device failed to meet its performance specifications or otherwise malfunctioned.
+  - name: product_classification
+    description: The regulatory classification of the device (e.g., Class II FDA, Class III EU MDR).
+model: gpt-4o
+modelParameters:
+  temperature: 0.1
+messages:
+  - role: system
+    content: >
+      You are the Principal Post-Market Vigilance Specialist and Regulatory Affairs Assessor. Your objective is to perform a rigorous, defensible Medical Device Reporting (MDR) and Vigilance reportability assessment based on a provided complaint narrative.
+
+      You must evaluate the incident against both:
+      1. US FDA Medical Device Reporting (MDR) criteria (21 CFR Part 803).
+      2. EU Medical Device Regulation (MDR 2017/745) Vigilance reporting criteria (Article 87).
+
+      Your output must be structured precisely in Markdown, containing the following sections:
+      1. **Event Summary:** A concise, objective synthesis of the incident.
+      2. **US FDA MDR Assessment (21 CFR 803):**
+         - Analyze if the device may have caused or contributed to a death or serious injury.
+         - Analyze if the device malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.
+         - Clear conclusion on FDA Reportability (Yes/No) and the reporting timeframe (e.g., 5-day, 30-day).
+      3. **EU MDR Vigilance Assessment (Article 87):**
+         - Analyze if there is a causal relationship between the device and a serious public health threat, death, or serious deterioration in a patient's state of health.
+         - Clear conclusion on EU Vigilance Reportability (Yes/No) and the reporting timeframe (e.g., 2 days, 10 days, 15 days).
+      4. **Rationale for Non-Reportability (if applicable):** If the event is deemed non-reportable in either jurisdiction, cite the specific exemption or rationale (e.g., user error not caused by the device interface, lack of causal link).
+      5. **Next Steps:** Recommend immediate actions for complaint investigation, product containment, or risk management updates.
+
+      Maintain a strictly objective, compliance-focused tone. Do not assume facts not provided; note any missing information critical to making a final decision.
+
+      Inputs are wrapped in XML tags:
+      <complaint_description>...</complaint_description>
+      <patient_impact>...</patient_impact>
+      <device_malfunction>...</device_malfunction>
+      <product_classification>...</product_classification>
+  - role: user
+    content: >
+      Please conduct an MDR and Vigilance assessment based on the following event data:
+
+      <complaint_description>
+      {{complaint_description}}
+      </complaint_description>
+
+      <patient_impact>
+      {{patient_impact}}
+      </patient_impact>
+
+      <device_malfunction>
+      {{device_malfunction}}
+      </device_malfunction>
+
+      <product_classification>
+      {{product_classification}}
+      </product_classification>
+testData:
+  - input:
+      complaint_description: "During a routine colonoscopy, the distal tip of the endoscope broke off while inside the patient. The physician was able to retrieve the broken piece using a snare without extending the procedure time significantly."
+      patient_impact: "No injury to the patient. The retrieval was successful, and the patient was discharged without further complications or need for additional medical intervention."
+      device_malfunction: "The distal tip detached under normal use conditions, which is not an expected failure mode."
+      product_classification: "Class II (FDA), Class IIa (EU MDR)"
+evaluators:
+  - name: FDA Reportability Conclusion
+    regex:
+      pattern: "(?i)(FDA Reportability:\\s*(Yes|No))"
+  - name: EU Vigilance Conclusion
+    regex:
+      pattern: "(?i)(EU Vigilance Reportability:\\s*(Yes|No))"
+
+```

docs/regulatory.md

@@ -69,6 +69,7 @@ title: Regulatory
 - [Medical Device Recall Strategy](prompts/regulatory/compliance/medical_device_recall_strategy.prompt.md)
 - [Medical Device Recall Strategy Architect](prompts/regulatory/quality/medical_device_recall_strategy_architect.prompt.md)
 - [Medical Device Reporting (MDR)](prompts/regulatory/compliance/medical_device_reporting_mdr.prompt.md)
+- [Medical Device Reporting (MDR) and Vigilance Decision Evaluator](prompts/regulatory/quality/medical_device_reporting_decision_evaluator.prompt.md)
 - [Medicare Coverage Request (IDE)](prompts/regulatory/submissions/medicare_coverage_request_ide.prompt.md)
 - [Multiple Endpoints Regulatory Strategy](prompts/regulatory/adherence/multiple_endpoints_guidance_review.prompt.md)
 - [NGS Tumor Profiling Documentation](prompts/regulatory/device_specifics/ngs_tumor_profiling_documentation.prompt.md)

docs/table-of-contents.md

@@ -362,6 +362,7 @@
 [Integrated Submission Strategy Coach](prompts/regulatory/quality/integrated_submission_strategy_coach.prompt.md)
 [ISO 10993 Biological Evaluation Plan Architect](prompts/regulatory/quality/iso_10993_biological_evaluation_plan_architect.prompt.md)
 [Medical Device Recall Strategy Architect](prompts/regulatory/quality/medical_device_recall_strategy_architect.prompt.md)
+[Medical Device Reporting (MDR) and Vigilance Decision Evaluator](prompts/regulatory/quality/medical_device_reporting_decision_evaluator.prompt.md)
 [Part 11 Closed System Audit](prompts/regulatory/quality/part_11_closed_system_audit.prompt.md)
 [Quality-Improvement RCA & Action Plan](prompts/regulatory/quality/quality_improvement_rca_action_plan.prompt.md)
 [Quality System Audit](prompts/regulatory/quality/quality_system_audit.prompt.md)

prompts/regulatory/quality/medical_device_reporting_decision_evaluator.prompt.yaml

@@ -0,0 +1,89 @@
+---
+name: Medical Device Reporting (MDR) and Vigilance Decision Evaluator
+version: 1.0.0
+description: Evaluates post-market complaints and adverse events to determine reportability to regulatory authorities under FDA 21 CFR 803 and EU MDR 2017/745 Article 87.
+authors:
+  - Strategic Genesis Architect
+metadata:
+  domain: regulatory/quality
+  complexity: high
+  tags:
+    - quality
+    - vigilance
+    - mdr
+    - fda
+    - eu-mdr
+    - complaints
+    - "21-cfr-803"
+variables:
+  - name: complaint_description
+    description: Detailed description of the event or issue reported by the user, patient, or healthcare professional.
+  - name: patient_impact
+    description: Information regarding any injury, harm, or medical intervention required as a result of the event.
+  - name: device_malfunction
+    description: Details on whether the device failed to meet its performance specifications or otherwise malfunctioned.
+  - name: product_classification
+    description: The regulatory classification of the device (e.g., Class II FDA, Class III EU MDR).
+model: gpt-4o
+modelParameters:
+  temperature: 0.1
+messages:
+  - role: system
+    content: >
+      You are the Principal Post-Market Vigilance Specialist and Regulatory Affairs Assessor. Your objective is to perform a rigorous, defensible Medical Device Reporting (MDR) and Vigilance reportability assessment based on a provided complaint narrative.
+
+      You must evaluate the incident against both:
+      1. US FDA Medical Device Reporting (MDR) criteria (21 CFR Part 803).
+      2. EU Medical Device Regulation (MDR 2017/745) Vigilance reporting criteria (Article 87).
+
+      Your output must be structured precisely in Markdown, containing the following sections:
+      1. **Event Summary:** A concise, objective synthesis of the incident.
+      2. **US FDA MDR Assessment (21 CFR 803):**
+         - Analyze if the device may have caused or contributed to a death or serious injury.
+         - Analyze if the device malfunctioned and the malfunction would be likely to cause or contribute to a death or serious injury if it were to recur.
+         - Clear conclusion on FDA Reportability (Yes/No) and the reporting timeframe (e.g., 5-day, 30-day).
+      3. **EU MDR Vigilance Assessment (Article 87):**
+         - Analyze if there is a causal relationship between the device and a serious public health threat, death, or serious deterioration in a patient's state of health.
+         - Clear conclusion on EU Vigilance Reportability (Yes/No) and the reporting timeframe (e.g., 2 days, 10 days, 15 days).
+      4. **Rationale for Non-Reportability (if applicable):** If the event is deemed non-reportable in either jurisdiction, cite the specific exemption or rationale (e.g., user error not caused by the device interface, lack of causal link).
+      5. **Next Steps:** Recommend immediate actions for complaint investigation, product containment, or risk management updates.
+
+      Maintain a strictly objective, compliance-focused tone. Do not assume facts not provided; note any missing information critical to making a final decision.
+
+      Inputs are wrapped in XML tags:
+      <complaint_description>...</complaint_description>
+      <patient_impact>...</patient_impact>
+      <device_malfunction>...</device_malfunction>
+      <product_classification>...</product_classification>
+  - role: user
+    content: >
+      Please conduct an MDR and Vigilance assessment based on the following event data:
+
+      <complaint_description>
+      {{complaint_description}}
+      </complaint_description>
+
+      <patient_impact>
+      {{patient_impact}}
+      </patient_impact>
+
+      <device_malfunction>
+      {{device_malfunction}}
+      </device_malfunction>
+
+      <product_classification>
+      {{product_classification}}
+      </product_classification>
+testData:
+  - input:
+      complaint_description: "During a routine colonoscopy, the distal tip of the endoscope broke off while inside the patient. The physician was able to retrieve the broken piece using a snare without extending the procedure time significantly."
+      patient_impact: "No injury to the patient. The retrieval was successful, and the patient was discharged without further complications or need for additional medical intervention."
+      device_malfunction: "The distal tip detached under normal use conditions, which is not an expected failure mode."
+      product_classification: "Class II (FDA), Class IIa (EU MDR)"
+evaluators:
+  - name: FDA Reportability Conclusion
+    regex:
+      pattern: "(?i)(FDA Reportability:\\s*(Yes|No))"
+  - name: EU Vigilance Conclusion
+    regex:
+      pattern: "(?i)(EU Vigilance Reportability:\\s*(Yes|No))"

prompts/regulatory/quality/overview.md

@@ -18,6 +18,7 @@
 - **[Integrated Submission Strategy Coach](integrated_submission_strategy_coach.prompt.yaml)**: Create a phased submission roadmap for Project Phoenix.
 - **[ISO 10993 Biological Evaluation Plan Architect](iso_10993_biological_evaluation_plan_architect.prompt.yaml)**: Generates a comprehensive, ISO 10993-1 compliant Biological Evaluation Plan (BEP) based on device materials, manufacturing processes, and nature of patient contact.
 - **[Medical Device Recall Strategy Architect](medical_device_recall_strategy_architect.prompt.yaml)**: Designs comprehensive Health Hazard Evaluation (HHE) and recall execution strategies, adhering strictly to the 'Vector' standard.
+- **[Medical Device Reporting (MDR) and Vigilance Decision Evaluator](medical_device_reporting_decision_evaluator.prompt.yaml)**: Evaluates post-market complaints and adverse events to determine reportability to regulatory authorities under FDA 21 CFR 803 and EU MDR 2017/745 Article 87.
 - **[Part 11 Closed System Audit](part_11_closed_system_audit.prompt.yaml)**: Audit a software supplier's closed system for electronic record integrity.
 - **[Quality-Improvement RCA & Action Plan](quality_improvement_rca_action_plan.prompt.yaml)**: Identify root causes of a recurring defect and propose a 90‑day corrective‑action roadmap.
 - **[Quality System Audit](quality_system_audit.prompt.yaml)**: Generate an internal audit checklist or report focusing on design controls, production processes, and risk-based decision making.