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UDI labelling requirements

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Regulatory basis - MDR Art. 27(4)–(6) / IVDR Art. 24(4)–(6) and MDR Annex VI Part C / IVDR Annex VI Part C. These provisions specify where and how the UDI carrier must appear on device labelling.

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Disclaimer - This site provides general information only and does not constitute legal or regulatory advice. Always consult the official regulation text and a qualified regulatory professional.

Where the UDI carrier must appear​

The UDI carrier (barcode, DataMatrix, or RFID) must appear on the label of the device or on its packaging. Where the same information is required at multiple packaging levels, a carrier must appear at each level:

Packaging levelUDI requirement
Unit of use / retail packageUDI carrier mandatory (UDI-DI + applicable UDI-PI)
Higher packaging levels (multipack, case)UDI carrier required (different UDI-DI for this packaging configuration)
Sterile barrier packaging (inner)UDI carrier required — enables scanning without opening sterile packaging
Device itself (direct part marking)Required for implantable devices where technically feasible

Human Readable Interpretation (HRI)​

The HRI is the text version of the UDI, which must appear adjacent to the UDI carrier. Format requirements:

  • Must contain the same information as the carrier
  • Must be legible without magnification aids
  • Where the device or packaging is too small, the HRI may appear on the next outer packaging level or on a folded leaflet

The HRI presents the UDI components as text — e.g.:

  • (01) 05012345678900 — UDI-DI (GTIN format)
  • (17) 250630 — Expiry date
  • (10) LOT2024A — Lot number

UDI-PI elements — by device type​

Device typeRequired UDI-PI elements on label
General devicesLot or batch number AND/OR serial number AND/OR manufacturing date AND/OR expiry date (as applicable to the device)
Sterile devicesExpiry date mandatory
Single-use devicesLot number
Reusable devicesSerial number
Software as a deviceSoftware version
Implantable devicesSerial number (for individual traceability)

Direct Part Marking (DPM) for implantable devices​

For implantable devices, the UDI (at minimum the UDI-DI) must be directly marked on the device where technically and clinically feasible. DPM methods include:

  • Laser engraving
  • Electrochemical etching
  • Ink marking

DPM must be durable, biocompatible, and legible under expected use conditions. If DPM is not feasible, the UDI appears on the packaging only, with justification documented.

Implant card — UDI link​

For implantable devices, the UDI information must be transferable to the patient's implant card — the document given to the patient listing the implanted device's identification details. The implant card must include at minimum the UDI-DI. See Implantable devices for implant card requirements.

Issuing entities — GS1, HIBCC, ICCBBA​

The three EU-recognised issuing entities each have specific carrier format requirements:

GS1​

  • UDI-DI format: GTIN (14-digit number, prefixed by company GS1 prefix)
  • Carrier formats: GS1-128 linear barcode, GS1 DataMatrix (2D), GS1 QR code, GS1 RFID
  • Application identifiers (AIs): standardised prefixes encode each data element (AI 01 = GTIN, AI 17 = expiry, AI 10 = lot, AI 21 = serial)
  • Registration: via national GS1 member organisations (e.g. GS1 UK, GS1 Germany)

HIBCC (Health Industry Business Communications Council)​

  • UDI-DI format: LIC (Labeler Identification Code) assigned by HIBCC + product number
  • Carrier formats: Code 39, Code 128, DataMatrix (all in HIBC format)
  • Identifier prefix: + (plus sign prefix on all HIBC encoded labels)
  • Registration: directly via HIBCC (hibcc.org)

ICCBBA​

  • Standard: ISBT 128
  • Primary use: blood and blood components, tissues, cellular therapy products and associated devices
  • Registration: via ICCBBA membership

Choosing an issuing entity​

Considerations when selecting an issuing entity:

  • Existing infrastructure: if already using GS1 barcodes for product traceability, extending to GS1 UDI is efficient
  • Supply chain compatibility: some hospital purchasing systems and pharmacy systems prefer specific carrier formats
  • Global harmonisation: GS1 is the predominant global standard; facilitates FDA UDI and other regulatory compliance simultaneously
  • Product type: ICCBBA is purpose-built for blood/tissue/cellular products

A manufacturer may use different issuing entities for different product lines — but consistency within a product line is recommended.

Official references​

ReferenceDescription
MDR Art. 27(4)–(6)UDI labelling requirements
MDR Annex VIUDI data elements
Commission Implementing Regulation (EU) 2017/2185Issuing entities
GS1 Healthcare UDI Implementation GuideGS1 UDI application guidance
HIBCC HIBC standardHIBCC UDI specification