Module28 April 20264 min read
Module spotlight: UDI, GUDID & EUDAMED
Modern device regulation runs on identification and databases. UDI records, GUDID submissions, and EUDAMED reports keep your device identity consistent across markets.
By MoniDoseQMS Team
Unique Device Identification is the backbone of modern traceability — the system that lets a device be tracked from manufacture to use, across borders and databases. Managing UDI records, GUDID submissions for the FDA, and EUDAMED reports for the EU keeps your device identity accurate everywhere it needs to be.
What you can do
- Maintain UDI records for your devices
- Prepare GUDID submissions for the United States
- Manage EUDAMED reports for the European Union
- Keep device identity consistent across markets and submissions
Why it matters
EU MDR and FDA rules both mandate UDI and database registration. Handling them inside the QMS — linked to technical documentation and registrations — avoids the duplicate data entry and mismatches that cause submission delays.