EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers, including AI/ML SaMD classification.
Project description
Mdr Medical Device MCP
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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 |
Refundable. UK Stripe — VAT-clean. Builds on the 81-MCP MEOK fleet. Verify any signed report at https://meok.ai/verify.
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_deviceto …" - "Use
classify_ivdto …" - "Use
samd_ai_ml_checkto …"
Project details
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