Mdr Medical Device Mcp
Wire EU MDR and IVDR regulatory checks into Claude Code or Cursor when scoping or documenting a medical device or IVD software product.
Overview
mdr-medical-device-mcp is a MCP server for the Ship phase that grounds AI agents in EU MDR and IVDR compliance expectations for medical device and IVD manufacturers.
What is this MCP server?
- Covers EU MDR (Reg 2017/745) and IVDR (Reg 2017/746) for device and IVD manufacturers
- Stdio MCP transport for local agent sessions without a separate HTTP service
- PyPI package mdr-medical-device-mcp at registry version 1.0.4
- Surfaces structured compliance context for agent-authored technical files and gap analysis
- Fits healthtech solo builders preparing notified-body or QMS conversations
- Server schema version 1.0.4 on PyPI identifier mdr-medical-device-mcp
- Stdio transport (no bundled HTTP port in server.json)
- Regulatory scope: EU MDR Reg 2017/745 and IVDR Reg 2017/746
What problem does it solve?
Health software founders waste cycles misreading EU device rules and risk shipping documentation that auditors will reject.
Who is it for?
Solo or indie builders in medtech, digital health, or IVD Saas who need agent-assisted EU regulatory drafting before audit or CE pathways.
Skip if: General wellness apps with no device claims, US-only FDA-only products, or teams that want certified legal advice instead of agent-assisted reference.
What do I get? / Deliverables
After you register the server, agents can cite MDR/IVDR-oriented compliance context while you draft technical files, risk summaries, and release checklists.
- Agent-accessible EU MDR/IVDR compliance tool surface over MCP
- Draft-ready regulatory narratives aligned to 2017/745 and 2017/746 framing
- Repeatable stdio integration for local compliance sessions
Recommended MCP Servers
Journey fit
How it compares
Regulatory-compliance MCP integration, not a substitute for notified-body or legal counsel.
Common Questions / FAQ
Who is mdr-medical-device-mcp for?
It is for small medical device and IVD software teams who want Claude Code or similar agents to respect EU MDR and IVDR framing while writing compliance artifacts.
When should I use mdr-medical-device-mcp?
Use it during security and launch prep when you are mapping device classification, technical documentation, or IVDR scope before submission or internal QA sign-off.
How do I add mdr-medical-device-mcp to my agent?
Install the PyPI package mdr-medical-device-mcp, add a stdio MCP entry pointing at that package in your client config, and restart Claude Code or Cursor so tools load at version 1.0.4.