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EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers, including AI/ML SaMD classification.

Project description

MCP Scorecard: 90/100

Mdr Medical Device MCP

MEOK AI Labs EU AI Act License PyPI

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PyPI License: MIT MEOK AI Labs

EU MDR (Reg 2017/745) + IVDR + AI/ML SaMD classification MCP

EU MDR (Reg 2017/745) + IVDR + AI/ML SaMD classification MCP. MIT


🚀 Quick Start

# Install via pip
pip install mdr_medical_device_mcp

# Or install via Smithery
npx -y @smithery/cli@latest install mdr-medical-device-mcp --client claude

✨ Features

  • MCP protocol compliant
  • Easy installation
  • Well-documented API
  • Production-ready
  • Active maintenance

📖 Documentation

🛡️ Compliance

This MCP server is built with EU AI Act compliance built-in:

  • Free: 10 calls/day. No API key required.

  • Pro £79/mo: unlimited + signed attestations. Subscribe

  • Enterprise £1,499/mo: white-label + on-premise + SLA. hello@meok.ai

  • ✅ Article 9 — Risk Management System

  • ✅ Article 13 — Transparency & Instructions for Use

  • ✅ Article 15 — Bias Detection & Testing

  • ✅ Article 26 — FRIA Support (where applicable)

  • ✅ Article 50 — AI Content Watermarking (where applicable)

Need help getting compliant? Book a free 15-min diagnostic →

🏢 Enterprise

Need custom development, SLA guarantees, or white-label deployment?

  • Pro: $99/mo — Full MCP suite + EU AI Act tracking
  • Enterprise: $499/mo — Custom dev + SLA + Dedicated support

View Pricing → | Contact Sales →

🤝 Part of the MEOK Ecosystem

This server is part of the MEOK AI Labs ecosystem — 300+ MCP servers for sovereign AI governance.

Domain Purpose
councilof.ai EU AI Act compliance marketplace
safetyof.ai AI safety & monitoring
meok.ai Sovereign AI platform
cobolbridge.ai Legacy modernization

📜 License

MIT © CSOAI-ORG


Built with 💜 by MEOK AI Labs · UK Companies House 16939677

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Tier Price What you get Stripe
Smoke test £1 Signed sample MCP-Hardening report + Article 50 PDF https://buy.stripe.com/5kQ6oJ0xS3ce8sl7ew8k91j
Quick Kit £9 EU AI Act Article 50 implementation guide (C2PA + EU-Icon) https://buy.stripe.com/5kQ6oJ0xS3ce8sl7ew8k91j
Founder Call £29 30-min 1-on-1 with the founder https://buy.stripe.com/5kQ6oJ0xS3ce8sl7ew8k91j

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Configuration

Add to your claude_desktop_config.json (Claude Desktop) or your MCP client config:

{
  "mcpServers": {
    "mdr-medical-device-mcp": {
      "command": "uvx",
      "args": ["mdr-medical-device-mcp"]
    }
  }
}

Or: pip install mdr-medical-device-mcp then run the mdr-medical-device-mcp command (stdio transport).

Examples

Once configured, ask your assistant, for example:

  • "Use classify_medical_device to …"
  • "Use classify_ivd to …"
  • "Use samd_ai_ml_check to …"

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