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EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers...
EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers...
This MCP server implements EU medical device regulation classification tools with reasonable code structure, but has several concerning patterns: unauthenticated access to all tools (auth is optional via api_key parameter with no enforcement), sensitive rate-limiting and auth logic that can be trivially bypassed, and aggressive monetization/upsell messaging embedded throughout. The server lacks proper input validation on classification queries and has no shell execution or file write risks. The rate-limiting implementation is bypassable since tier detection via optional api_key is not enforced, allowing free tier users to bypass daily limits. Supply chain analysis found 3 known vulnerabilities in dependencies (0 critical, 3 high severity). Package verification found 1 issue.
4 files analyzed · 12 issues found
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Add this to your MCP configuration file:
{
"mcpServers": {
"io-github-csoai-org-mdr-medical-device-mcp": {
"args": [
"mdr-medical-device-mcp"
],
"command": "uvx"
}
}
}From the project's GitHub README.
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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
# 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
This MCP server is built with EU AI Act compliance built-in:
Free: 10 calls/day. No API key required.
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✅ 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)
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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 |
MIT © CSOAI-ORG
| 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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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).
Once configured, ask your assistant, for example:
classify_medical_device to …"classify_ivd to …"samd_ai_ml_check to …"Be the first to review this server!
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