
If you're building medical device software that needs to navigate EU MDR (2017/745) or IVDR (2017/746), this server gives Claude direct access to compliance classification tools. It exposes three main operations: classify_medical_device for general devices, classify_ivd for in vitro diagnostics, and samd_ai_ml_check for AI/ML-based software as a medical device. The server also surfaces EU AI Act compliance helpers for risk management, transparency, and bias detection. Made by MEOK AI Labs, it's MIT licensed with a free tier and paid tiers that add signed attestation reports for audits. You'd reach for this when you need Claude to help classify a product, generate compliance documentation, or check AI/ML device requirements without leaving your conversation.
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Buy Starter โ ยฃ29/mo
Signed attestations + unlimited audits + email support. ๐ Subscribe at meok.ai โ 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
# 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.
Pro ยฃ79/mo: unlimited + signed attestations. Subscribe
Enterprise ยฃ1,499/mo: white-label + on-premise + SLA. hello@meok.ai
โ Article 9 โ Risk Management System
โ Article 13 โ Transparency & Instructions for Use
โ Article 15 โ Bias Detection & Testing
โ Article 26 โ FRIA Support (where applicable)
โ Article 50 โ AI Content Watermarking (where applicable)
Need help getting compliant? Book a free 15-min diagnostic โ
Need custom development, SLA guarantees, or white-label deployment?
View Pricing โ | Contact Sales โ
This server is part of the MEOK AI Labs ecosystem โ 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 ยฉ CSOAI-ORG
Built with ๐ by MEOK AI Labs ยท UK Companies House 16939677
| Tier | Price | What you get | Stripe |
|---|---|---|---|
| Smoke test | ยฃ1 | Signed sample MCP-Hardening report + Article 50 PDF | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
| Quick Kit | ยฃ9 | EU AI Act Article 50 implementation guide (C2PA + EU-Icon) | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
| Founder Call | ยฃ29 | 30-min 1-on-1 with the founder | https://buy.stripe.com/aFa7sNcgAdQS0ZT1Uc8k91t |
Refundable. UK Stripe โ VAT-clean. Builds on the 81-MCP MEOK fleet. Verify any signed report at https://meok.ai/verify.
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 โฆ"classify_ivd to โฆ"samd_ai_ml_check to โฆ"mdr-medical-device-mcp