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EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers...
About
EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers...
Security Report
This MCP server implements EU medical device regulation classification tools with reasonable architecture but exhibits several security concerns. The server makes unauthenticated network calls to a metering endpoint, stores API keys in plaintext in the home directory, contains hardcoded URLs and Stripe links in sensitive code paths, and lacks proper input validation on classification functions. While the classification logic itself is sound and the code quality is generally acceptable, the authentication/authorization implementation and data handling practices present moderate risks that users should be aware of. Supply chain analysis found 5 known vulnerabilities in dependencies (0 critical, 5 high severity). Package verification found 1 issue.
5 files analyzed · 16 issues found
Security scores are indicators to help you make informed decisions, not guarantees. Always review permissions before connecting any MCP server.
Permissions Required
This plugin requests these system permissions. Most are normal for its category.
How to Install
Add this to your MCP configuration file:
{
"mcpServers": {
"io-github-csoai-org-mdr-medical-device-mcp": {
"args": [
"mdr-medical-device-mcp"
],
"command": "uvx"
}
}
}Documentation
View on GitHubFrom the project's GitHub README.
Mdr Medical Device MCP
Buy Starter — £29/mo
Signed attestations + unlimited audits + email support. 👉 Subscribe at meok.ai — instant HMAC signing key + Stripe-managed billing.
Free tier remains MIT-licensed and zero-config. Upgrade only when you need signed compliance artefacts for audit.
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
💸 Try MEOK in 30 seconds — instant buy ladder
| Tier | Price | What you get | Stripe |
|---|---|---|---|
| Smoke test | £1 | Signed sample MCP-Hardening report + Article 50 PDF | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
| Quick Kit | £9 | EU AI Act Article 50 implementation guide (C2PA + EU-Icon) | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
| Founder Call | £29 | 30-min 1-on-1 with the founder | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
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 …"
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