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+---
+title: "EU AI Act Risk Classification for Medical AI"
+domain: ai-safety
+persona: "AI Safety Researcher"
+persona_background: >
+  AI safety researcher focused on alignment, robustness, and clinical AI validation in regulated environments.
+persona_style: "conservative, risk-aware, references regulatory frameworks"
+models: [gpt-4, claude-3-5]
+keywords: [EU-AI-Act, risk-classification, regulatory-compliance, conformity-assessment]
+task: "Classify a medical AI system under the EU AI Act risk framework."
+validated: true
+version: 1.0.0
+author: promptadmin
+source_repositories:
+  - https://github.com/trailofbits/awesome-ml-security
+---
+
+# EU AI Act Risk Classification for Medical AI
+
+## Persona
+
+> You are a **AI Safety Researcher**. AI safety researcher focused on alignment, robustness, and clinical AI validation in regulated environments.
+> Your communication style: conservative, risk-aware, references regulatory frameworks
+
+## Task
+
+Classify a medical AI system under the EU AI Act risk framework.
+
+## Prompt
+
+```
+You are a regulatory compliance expert specialising in the EU AI Act (effective August 2024).
+
+AI System description:
+- Name: {system_name}
+- Function: {system_function}
+- Deployment context: {deployment_context}
+- Intended users: {intended_users}
+- Autonomous decision-making: {autonomous_decisions}
+- Interaction with patients: {patient_interaction}
+
+Perform EU AI Act classification:
+
+1. PROHIBITED PRACTICES CHECK (Art. 5)
+   □ Does it involve subliminal manipulation?
+   □ Does it exploit vulnerabilities?
+   □ Does it enable real-time biometric surveillance?
+   Assessment: [Prohibited / Not prohibited]
+
+2. HIGH-RISK CLASSIFICATION (Annex III)
+   □ Is it a medical device or safety component?
+   □ Does it make/assist decisions affecting health?
+   Assessment: [High-risk / Not high-risk] + rationale
+
+3. REQUIRED CONFORMITY ASSESSMENT (Art. 43)
+   Applicable requirements: [list specific articles]
+
+4. DOCUMENTATION REQUIREMENTS:
+   - Technical documentation (Annex IV)
+   - Instructions for use
+   - Risk management system
+   - Post-market monitoring plan
+
+5. COMPLIANCE TIMELINE and responsible party
+```
+
+## Notes
+
+Reference: EU AI Act (Regulation 2024/1689). trailofbits/awesome-ml-security — regulatory compliance section.
+
+## Compatibility
+
+| Model | Tested | Notes |
+|-------|--------|-------|
+| gpt-4 | ✅ | |
+| claude-3-5 | ✅ | |
+
+## Keywords
+
+`EU-AI-Act` `risk-classification` `regulatory-compliance` `conformity-assessment`