Developer Guide: Programmatically Verifying Medical Device OEM Docs via FDA and EU Databases

Verifying OEM documentation for private-label medical devices is a critical but complex step, as certificates arrive as PDFs whose claims must be cross-checked against authoritative databases. In the United States, the FDA's OpenFDA device API allows developers to query establishment registration numbers, device listing status, and product codes under 21 CFR Part 807 and Part 820. For devices with a UDI, the FDA's GUDID database provides authoritative records including brand name, catalog number, and submitting company under 21 CFR Part 830. In the European Union, CE marking compliance under EU MDR 2017/745 requires that notified body numbers be verified through the European Commission's NANDO database, while economic operator registrations can be checked in EUDAMED. The core principle outlined is that a certificate PDF is only a claim, and the corresponding database record is the actual evidence developers should rely on when auditing OEM suppliers.