Unique Device Identifier (UDI)

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What it is

Unique Device Identifier (UDI) is a globally unique code set that identifies a specific medical device model and its production details across the product lifecycle. It improves traceability, recalls, and post-market surveillance. Regulatory bases include EU MDR/IVDR (MDR Arts. 27–28; Annex VI Part C) and US FDA rules (21 CFR 801 Subpart B; 21 CFR 830; direct marking 21 CFR 801.45).

Traceability & safetyLabel & databaseGlobal standards

Regulatory framework

  • EU (MDR/IVDR): UDI system requirements, Basic UDI-DI, carrier on label/pack, direct marking where applicable; device data registration in EUDAMED UDI/Devices (MDR Arts. 27–29; Annex VI Parts A–C).
  • US (FDA): UDI on labels/packaging (21 CFR 801.20), direct marking for reprocessed/reused items (21 CFR 801.45), issuing agency formats (21 CFR 830.100), and device data submission to GUDID (21 CFR 830.300).
  • Issuing agencies/standards: GS1, HIBCC, ICCBBA formats; AIDC (barcode/other) plus HRI (human-readable) per jurisdictional rules.

Key elements

  • UDI-DI: Fixed device identifier (model/version).
  • UDI-PI: Production identifier(s) (lot, serial, expiry, manufacture date, software build, as required).
  • Basic UDI-DI (EU): Primary key for device family/technical documentation and certificates; not on the label.
  • Carrier: AIDC + HRI on label/pack; direct marking when required.
  • Databases: EU EUDAMED UDI/Devices; US GUDID.

Process — how it works

  • Structure: Assign Basic UDI-DI (EU) and UDI-DI using an approved issuing agency; define UDI-PI elements by risk and process controls.
  • Label: Place AIDC and HRI on device/pack; apply direct marking if the device is intended for multiple reuses and reprocessed between uses (e.g., 21 CFR 801.45; MDR Annex I §23 where applicable).
  • Register: Submit required UDI data sets to the regulator database (EU EUDAMED; US GUDID) before or at market placement, per local rules.
  • Maintain: Keep data current after changes (model, label, sterilization, end of marketing) and ensure UDI is in technical documentation and PMS records.
  • Use: Embed UDI in QMS processes (receiving, production control, DHR/traceability, complaints, vigilance, recalls).

Common pitfalls

  • Mismatched UDI data between label, EUDAMED/GUDID, and the technical file.
  • Confusing Basic UDI-DI (EU) with the on-label UDI-DI.
  • Missing or incorrect direct marking on reusable devices.
  • UDI-PI content that does not reflect real production controls (lot/serial/expiry).
  • Outdated database entries after design or labeling changes.

Quick checks

  • Does every marketed package level carry the correct UDI carrier (AIDC + HRI)?
  • Is the Basic UDI-DI used consistently across CER, GSPR matrix, DoC, and NB certificates (EU)?
  • Are EUDAMED/GUDID records complete, current, and aligned with labels and IFU?
  • Do QMS procedures use UDI in receiving, DHR, PMS, vigilance, and recalls?

FAQ

What is the difference between UDI-DI and UDI-PI?

UDI-DI is the fixed model identifier; UDI-PI contains variable production data like lot, serial, and expiry. Together they provide unique identification at distribution/use.

What is Basic UDI-DI and is it on the label?

In the EU, it is the primary identifier for a device group in technical documentation, certificates, and EUDAMED. It does not appear on the product label.

Do all devices need direct part marking?

No. It is required when devices are intended to be reused and reprocessed between uses or as specified by law (e.g., 21 CFR 801.45 and relevant MDR rules).

Which barcode standard should we use?

Use a format from a recognized issuing agency (GS1, HIBCC, ICCBBA) that meets local rules for AIDC and HRI content.

When must we submit UDI data to a database?

Before or at market placement as required: to GUDID in the US (21 CFR 830.300) and to EUDAMED UDI/Devices in the EU when that module is mandatory for your device.