UDIs are issued by FDA-accredited or EU-designated issuing agencies. The three most widely used are GS1, HIBCC, and ICCBBA. Manufacturers select an accredited agency and follow its standard to construct their UDIs.

Where are UDIs stored?

In the U.S., UDI data is submitted to the FDA Global Unique Device Identification Database (GUDID) and made public through AccessGUDID. In the EU, UDI data is registered in EUDAMED under MDR and IVDR.

Do Class I devices need a UDI?

Yes, most Class I devices require UDI in both the U.S. and EU, though timelines and specific exemptions differ. Direct marking requirements typically apply to reusable devices that are reprocessed between uses.

All terms

RegulatoryRegulated Pathways Manufacturing & SupplyUDI

Unique Device Identification

System for adequate identification of medical devices through distribution and use.

Reviewed by Christian Espinosa, Founder, Blue Goat CyberLast reviewed May 5, 2026

Definition

Unique Device Identification (UDI) is a system that uses an alphanumeric code to uniquely identify a medical device through its distribution and use. It comprises a Device Identifier (DI) and a Production Identifier (PI), and is registered in the GUDID (US) or EUDAMED (EU).

What this means in practice

UDI supports recall management, adverse event reporting, and supply chain traceability. It is mandatory in the U.S., EU, and an increasing number of jurisdictions. The Device Identifier (DI) is the fixed portion that identifies the labeler and specific version or model. The Production Identifier (PI) is a conditional, variable portion that may include lot or batch number, serial number, expiration date, manufacturing date, and (for HCT/Ps) the distinct identification code.

Examples

A pacemaker labeled with a GS1-issued UDI containing a GTIN as the DI and lot number plus expiration date as the PI.
An implantable orthopedic screw carrying a direct-part-marked UDI so it remains identifiable after unpacking.

Use cases

1 scenario

EU MDR labeling refresh across 200 SKUs

Labeling specialist

The team assigns UDI-DI/UDI-PI to every SKU using a GS1 issuing agency, prints AIDC and HRI on labels, and uploads device data to EUDAMED. Production scanners verify each label before release.

OutcomeDevices ship into the EU on time; hospitals can scan UDIs into their inventory and adverse event reports.

Common pitfalls

•Confusing UDI-DI with UDI-PI. Regulators, GUDID, and EUDAMED all expect both to be handled correctly on labels and in submissions.
•Assuming a single UDI covers every package level. Each package configuration (unit, box, case) needs its own DI.
•Not updating GUDID or EUDAMED when labeling, sterilization method, or configuration changes.
•Treating UDI as a labeling-only task. It touches PLM, ERP, regulatory, and post-market systems.

Frequently asked questions

UDI-DI (Device Identifier) is the fixed identifier for a specific device version or model and its packaging level. UDI-PI (Production Identifier) is the variable portion that identifies the specific production unit, typically including lot or batch number, serial number, expiration date, or manufacturing date.

Cross-references

Used by

Things that build on this term.

Contains

Sub-elements or required artefacts of this term.

UDI-DI vs. UDI-PI

Shared paths + category

Regulatory

EUDAMED

European Database on Medical Devices.

EU MDR Essentials · adjacent

Regulatory

EU Medical Device Regulation(MDR)

Regulation (EU) 2017/745 governing medical devices in the European Union.

EU MDR Essentials

Post-Market

Global Unique Device Identification Database(GUDID)

FDA database holding key device identification information for all UDIs.

Post-Market

Post-Market Surveillance(PMS)

Activities to monitor device safety and performance after market release.

Regulatory

CE Mark

Mandatory European conformity mark for medical devices placed on the EU market.

EU MDR Essentials

Regulatory

EU In Vitro Diagnostic Regulation(IVDR)

Regulation (EU) 2017/746 governing in vitro diagnostic medical devices in the EU.

EU MDR Essentials

Latest in MedTech

Primary references

3 sources

Link health: 2 verified 1 unchecked· last checked 2026-06-20

FDA·1NIH / FDA·1European Commission·1

Inline markers like [1] jump to the matching reference above.

On this term

Category: Regulatory
Acronym: UDI
Sources: 3
Use cases: 1
Updated: 5/5/2026

Compare with another term

Learn in 60 seconds

System for adequate identification of medical devices through distribution and use.

·UDI supports recall management, adverse event reporting, and supply chain traceability.
·It is mandatory in the U.S., EU, and an increasing number of jurisdictions.
·The Device Identifier (DI) is the fixed portion that identifies the labeler and specific version or model.

Remember this

Watch out: Confusing UDI-DI with UDI-PI. Regulators, GUDID, and EUDAMED all expect both to be handled correctly on labels and in submissions.

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