EUDAMED Device Registration Change Monitor

EUDAMED Device Registration Change Monitor tracks matched records in the public UDI/Devices module by UDI-DI, Basic UDI-DI, or exact trade name. Create a baseline once, then schedule recurring checks to receive a focused feed of records that are new or have changed.

Independent tool. Not affiliated with, endorsed by, or sponsored by the European Commission or EUDAMED.

What EUDAMED device records can you monitor?

Monitor up to 30 exact device identifiers and 20 exact public trade names in one watchlist. Identifier searches provide the most precise match. The first tracked run saves a baseline; later runs compare the latest public record with that baseline and return changes by default. Turn on unchanged records when you need a full current snapshot instead.

This Actor covers only publicly available records from EUDAMED’s UDI/Devices module. It does not monitor actor registration, notified bodies and certificates, vigilance, clinical investigations, market surveillance, or any other EUDAMED module.

Public UDI/Devices data

Each matched row can include:

• Primary UDI-DI and Basic UDI-DI
• Trade name, device name, model, and reference
• Manufacturer name and SRN when published
• Authorised representative details when published
• Public risk-class, device-status, and manufacturer-status codes
• Match reason, change type, and changed fields
• Observation time and direct official-source link

How to monitor EUDAMED device registrations

1. Add exact UDI-DI or Basic UDI-DI values, exact public trade names, or both.
2. Give the watchlist a recognizable monitor name.
3. Keep change tracking enabled and reuse the same snapshot-store name.
4. Run once to establish the baseline, then schedule recurring checks.

Example input

{
  "deviceIdentifiers": ["D924360030EU1"],
  "tradeNames": ["Exact Public Trade Name"],
  "monitorName": "cardiology-watchlist",
  "trackChanges": true,
  "includeUnchanged": false
}

Medical device monitoring use cases

• Follow known devices or device families during supplier review
• Watch published competitor device identifiers
• Maintain a change feed for regulatory and quality teams
• Review public manufacturer or device-status changes
• Build recurring market-intelligence datasets around named devices

Pricing

You pay only for public device rows written to the dataset. Empty searches, source errors, and unchanged records omitted by change-only mode do not create a paid output row. Use the record limit and an Apify run spending limit for cost control.

Frequently asked questions

Does this monitor cover all of EUDAMED?

No. It covers only public UDI/Devices records and does not search or monitor other EUDAMED modules.

Can I search by a partial trade name?

Use the exact public trade name for dependable matching. Prefer a UDI identifier whenever one is available.

How are changes detected?

The monitor compares matched public fields with the stored baseline for the same watchlist and labels new, changed, unchanged, or current records.

Limitations

Public-register coverage and fields are controlled by EUDAMED and can change or be corrected at the source. Codes are returned as published and should be verified using the official link. The output is a monitoring and research aid, not a regulatory determination, conformity assessment, clinical recommendation, or safety alert.