Regulatory classification decides the evidence burden, and the same device can be Class II in one market and Class III in another. A tool that answered per jurisdiction would leave the caller assembling the comparison that actually matters. The pathway finder addresses the follow-on question directly — given approval here, what is the route to there — which is otherwise consultancy work. Treat the output as orientation rather than as a filing position: classifications turn on device-specific detail and intended use, and an API answer is a starting point for a regulatory professional, not a substitute for one.
A medical-device regulatory client with four tools: device classification across jurisdictions, the supported jurisdiction list, a cross-jurisdiction pathway finder, and a regulatory alerts feed.
- classify_device returns the classification across global jurisdictions rather than for one, which is the comparison that determines market strategy.
- find_pathway returns the regulatory route between two jurisdictions for a specific device — the question asked when a device is approved in one market and heading for another.
- get_alerts queries recent alerts from the FDA, EU-MDCG and HSA together, with analysis attached.
- list_jurisdictions returns what is supported with detail, so coverage is knowable before a question is built on it.
REGMD_API_KEY.
One command plus a key — npx regmd-mcp, then supply credentials