EUDAMED MCP

Independent, unofficial integration.

EUDAMED MCP

Search European medical-device records from your AI assistant.

Independent, unofficial integration · Read-only access · No API key required for the public endpoints tested

A read-only Model Context Protocol server for the European Commission's EUDAMED Public API. Search UDI records, verify economic operators, decode classification and status values, and investigate a device without losing the distinction between a public record and verified conformity evidence.

Start with a company name, device name or UDI. Find candidate records, identify the registered manufacturer and build an evidence checklist with source links and explicit gaps.

5 tools · 3 guided workflows · 5 readable resources

Get started · Example requests · How evidence works · Official EUDAMED portal

What makes it useful

• Identity before interpretation. Preserve leading zeroes in UDIs, apply exact matching locally, and keep multiple candidates visible.
• Find the actual manufacturer. A supplied SRN can belong to another company in the same group. Investigation searches device identity independently and follows the manufacturer SRN in the returned record.
• Evidence you can trace. Results carry the exact source query, original retrieval timestamp, API version, cache status and local limits.
• Honest gaps. Missing flags remain unknown. Failed requests remain failures. IFUs, declarations and certificates remain unverified until obtained separately.
• Small tool surface. Five tools expose the three verified API endpoints and a bounded investigation workflow. Prompts are also resources, so clients can read the procedures without invoking a slash command.
• Conservative by default. Serialized requests, bounded retries, timeouts, response-size limits, short-lived caching and organizational-only actor data.

This is an independent integration, not an official European Commission product. Public registration does not independently establish product conformity. The server does not retrieve IFUs or certificates and does not issue a compliant/non-compliant verdict.

Install and connect

Requires Node.js 22 or later. Add this entry to your MCP client's server configuration:

{

"mcpServers": { "eudamed": { "command": "npx", "args": ["-y", "@t4dhg/mcp-eudamed@0.1.1"] } } }

To build from source, run npm ci && npm run build in the checkout and configure node with the absolute path to dist/cli.js.

The server uses stdio. Standard output is reserved for MCP messages. No credentials or .env file are needed. Optional configuration is read from the process environment; .env files are not loaded automatically.

For programmatic use, import EudamedClient, investigate or createServer from the package. Importing the library does not start a transport:

import { EudamedClient, investigate } from '@t4dhg/mcp-eudamed';

const api = new EudamedClient(); const results = await api.devices({ primaryDi: 'YOUR_PRIMARY_UDI_DI', exact: true, });

const dossier = await investigate(api, { manufacturerSrn: 'US-MF-000000001', tradeName: 'YOUR_DEVICE_NAME', });

Try these requests

Find the public EUDAMED record for this Primary UDI-DI. Show the legal manufacturer, authorised representative, risk class and the exact source query.

I have a manufacturer SRN and a product name, but the manufacturer search is empty. Check whether the product is registered under a different legal entity.

Build an evidence checklist for this device. Separate what EUDAMED says from what still needs a controlled IFU, declaration or certificate.

Tools

All tools advertise read-only, non-destructive, idempotent, open-world annotations. Tool errors return isError: true. Search tools provide JSON text and equivalent structuredContent. Investigation provides a concise report in text content and complete evidence in structuredContent (also including the report).

Search a device

{

"primaryDi": "YOUR_PRIMARY_UDI_DI", "exact": true, "limit": 10, "language": "en", "raw": true }

exact defaults to false for discovery. When true, every supplied filter is compared locally using trimmed, case-insensitive equality. Do not assume upstream partial-name matching; use exact known identifiers and inspect the returned evidence. Multiple filters are sent together; the observed upstream behavior is AND, but it is not a published contractual guarantee.

The device tool returns normalized identity, operators, decoded values, tri-state flags, intended-purpose status and unverified document checklists. Set raw: true to retain additional upstream device fields. The library's devices() method always returns validated raw device records.

Investigate a manufacturer mismatch

{

"manufacturerSrn": "YOUR_SUPPLIED_SRN", "tradeName": "YOUR_DEVICE_NAME", "maxDevices": 10, "maxManufacturers": 3, "maxRepresentatives": 3 }

The workflow:

1. Query Primary DI first, then Basic UDI, then each supplied name/reference independently with exact local matching. A stale name cannot suppress an exact UDI result.
2. Look up the supplied actor and its returned device portfolio.
3. Use the strongest nonempty route as target candidates, record conflicts with other supplied fields, and preserve alternative route candidates. Read manufacturer SRNs from target candidates and inspect their actors and bounded portfolios.
4. Verify authorised representatives for the selected evidence records.
5. Decode reference values and list the controlled documents still unverified.
6. Return query provenance, failures, omitted counts and unknown upstream coverage.

targetEvidence contains only target candidates from the strongest nonempty identity route. portfolioEvidence contains other manufacturer records and must not be attributed to the target. evidence remains a compatibility alias for target evidence only. Manufacturer-only investigations have no target evidence.

searches retains each independent query. conflicts records supplied-versus-observed disagreements; alternativeCandidates retains other search-route matches. identityStatus distinguishes identifier matches, candidates, ambiguity, conflicts, not-found, unresolved and portfolio-only results. Multiple versions remain separate candidates; the server does not automatically choose the latest. Missing operator identities and unmatched actor lookups appear in unresolved.

status: "completed" means execution completed, not that identity, documents or conformity have been established. partial, timed-out and cancelled retain gathered evidence and its limits. The concise report lists target identity, decoded fields, evidence gaps, conflicts, failures, bounds and next documents needed. Detailed records remain available in structured output.

Prompts and resources

Each prompt takes a required query string containing known identifiers, names or the investigation question. Prompts supply procedures; they do not fetch data themselves.

Readable resources:

• eudamed://guides/search
• eudamed://guides/evidence
• eudamed://prompts/investigate_device
• eudamed://prompts/manufacturer_portfolio
• eudamed://prompts/conformity_evidence

Understand the evidence

| coverage: "unknown" | Registry coverage and individual-record freshness are not established