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

## Install
```bash
pip install mdr-medical-device-mcp
```

## Auth & Rate Limits
- Free tier: 10 calls/day. No API key required.
- Pro tier (£79/mo): unlimited + signed attestations.
- Enterprise (£1,499/mo): white-label + on-premise.

## Tools (5)

### `classify_medical_device(query, api_key)`
MDR Annex VIII risk classification (Class I/IIa/IIb/III)

### `classify_ivd(query, api_key)`
IVDR Annex VIII IVD classification (Class A/B/C/D)

### `samd_ai_ml_check(query, api_key)`
AI/ML SaMD classification + IMDRF risk framework

### `ce_marking_requirements(query, api_key)`
MDR Article 19 CE marking + Notified Body involvement

### `eudamed_registration(query, api_key)`
EUDAMED UDI-DI + Basic UDI registration requirements

## Pairs with
- `meok-attestation-api` — HMAC signing for compliance certs
- `meok-attestation-verify` — public verification

## Maintainer
MEOK AI Labs · hello@meok.ai · https://meok.ai · MIT
