mdr-medical-device-mcp 1.0.3

EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) compliance for medical device + IVD manufacturers, including AI/ML SaMD classification.

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 certs
• meok-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. [e-mail]

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 [e-mail] for sponsored development.

License

MIT © MEOK AI Labs