EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers, including AI/ML SaMD classification.
Project description
EU Medical Device Regulation (MDR) MCP
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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.
Install
pip install mdr-medical-device-mcp
Tools
| Tool | Purpose |
|---|---|
classify_medical_device |
MDR Annex VIII risk classification (Class I/IIa/IIb/III) |
classify_ivd |
IVDR Annex VIII IVD classification (Class A/B/C/D) |
samd_ai_ml_check |
AI/ML SaMD classification + IMDRF risk framework |
ce_marking_requirements |
MDR Article 19 CE marking + Notified Body involvement |
eudamed_registration |
EUDAMED UDI-DI + Basic UDI registration requirements |
Pairs with
meok-attestation-api— POST results to https://meok-attestation-api.vercel.app/sign for cryptographically signed compliance certsmeok-attestation-verify— public verification of any MEOK-signed cert- Other MEOK governance MCPs via SOV3
mcp_bridge_call
Pricing
- 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
Status
Scaffold v1.0.0 ships the MCP framework + 5 tool stubs. v1.1.0 will add real regulation data ingestion.
If your team needs this MCP fully-loaded faster, ping hello@meok.ai for sponsored development.
License
MIT © MEOK AI Labs
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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/dRmcN75ScdQS7oh1Uc8k90U |
| Quick Kit | £9 | EU AI Act Article 50 implementation guide (C2PA + EU-Icon) | https://buy.stripe.com/cNi00la8s1460ZT0Q88k90V |
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Refundable. UK Stripe — VAT-clean. Builds on the 81-MCP MEOK fleet. Verify any signed report at https://meok.ai/verify.
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