Guide
What is UDI? Unique Device Identification explained
A Unique Device Identifier (UDI) is a code that identifies a medical device through distribution and use. It appears on the label in plain text and in a machine-readable form such as a barcode, and its core data is submitted to a public database — GUDID in the United States and EUDAMED in the European Union.
The basics
How a UDI is built and used
UDI-DI: the device identifier
The static part of the UDI. It identifies the labeler and the specific version or model of the device, and is the key used to look the device up in GUDID or EUDAMED.
UDI-PI: the production identifier
The variable part, used when it appears on the label: lot or batch number, serial number, manufacturing date, expiration date and, for certain tissue-based devices, a distinct identification code.
Issuing agencies
UDIs are created under a standard from an accredited issuing agency. In the US the FDA has accredited GS1, HIBCC and ICCBBA; the EU designates issuing entities including these same organisations.
Databases: GUDID and EUDAMED
Labelers submit device attributes — brand, model, sterility, MRI safety, packaging levels and more — to FDA's Global Unique Device Identification Database. Under EU MDR and IVDR the equivalent is the UDI/device module of EUDAMED, which also uses a Basic UDI-DI.
Getting it right
Keeping UDI data consistent
- 1Choose an issuing agency and set up your company prefix and numbering scheme.
- 2Assign a UDI-DI to each device version and package level, and a new one whenever a change triggers it.
- 3Put label artwork under document control so the human-readable and barcode forms always match the record.
- 4Submit and maintain device records in GUDID and, for the EU market, EUDAMED.
- 5Capture UDIs on distribution, complaint and implant records so traceability works in both directions.
Where Qevatrix fits
UDI data that stays in one place
DeviceOS and RegulatoryOS pull device records from FDA's AccessGUDID automatically, so catalogue data is not re-keyed, and link each UDI-DI to its labels, registrations, complaints and implant records.
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This guide is an orientation, not regulatory advice. Confirm requirements and compliance dates against 21 CFR Part 830, 21 CFR 801 Subpart B, EU MDR/IVDR and your issuing agency's current rules.