UDI Issuing Agencies Compared: GS1, HIBCC, ICCBBA and IFA — Which One to Use and Why
Before you can print a single UDI label you have to pick who issues the numbers. Regulators do not issue UDIs; they accredit agencies whose numbering systems meet the rules. There are four, and the choice shapes your code structure, your barcodes, your annual costs and, to a degree, who can scan you. This is the comparison.
Key points
- FDA-accredited: GS1, HIBCC, ICCBBA. EU-designated: the same three plus IFA (PPN).
- Every UDI = DI (static, registered) + PI (variable: lot, serial, dates, software).
- GS1 = numeric GTIN + Application Identifiers; HIBCC = alphanumeric HIBC; ICCBBA = ISBT 128 for products of human origin; IFA = PPN, mostly German pharma/medtech.
- One agency can serve both markets; most exporters pick GS1 or HIBCC and use DataMatrix.
1. The four agencies
| Agency | System / identifier | Accepted by | Typical users | Cost model |
|---|---|---|---|---|
| GS1 | GTIN (GTIN-14 in AI (01)) with Application Identifiers for PI | FDA, EU MDR/IVDR, most other UDI regimes | The majority of device manufacturers; anyone also in retail/hospital logistics | Company prefix licence + annual fee tied to prefix capacity |
| HIBCC | HIBC — Labeler Identification Code (LIC) + product code, alphanumeric | FDA, EU MDR/IVDR | Healthcare-only manufacturers, especially US, dental, orthopaedic | Flat annual fee per labeller, independent of product count |
| ICCBBA | ISBT 128 — Facility Identification Number + product description codes | FDA, EU MDR/IVDR | Medical products of human origin: blood, tissue, cells, milk banks | Annual licence per facility |
| IFA GmbH | PPN (Pharmazentralnummer-based Product Number) | EU MDR/IVDR (not FDA) | German and Austrian pharma and medtech already using PZN | Fee per registration through IFA |
2. Anatomy of a UDI under each system
Device Identifier (DI)
- GS1: a 14-digit GTIN carried in AI
(01). Your company prefix + item reference + check digit. One GTIN per device model/version and per packaging level. - HIBCC: a Primary Data Structure starting with
+, containing the 4-character LIC, a product/catalogue number of up to 18 alphanumerics, a unit-of-measure digit and a check character. - ICCBBA: ISBT 128 product identification using the Facility Identification Number and standardized product description codes; the DI is built from these fixed elements.
- IFA: a PPN derived from the German PZN, with a fixed structure and check digits.
Production Identifier (PI)
| PI element | GS1 AI | HIBCC (Secondary Data Structure) | ICCBBA ISBT 128 |
|---|---|---|---|
| Lot / batch | (10) | $ or $$ prefix with lot | Lot number data structure |
| Serial number | (21) | $+ prefix with serial | Serial data structure |
| Manufacturing date | (11) YYMMDD | Date formats within secondary structure | Date structures |
| Expiry date | (17) YYMMDD | $$ with date in defined formats | Expiration date structure |
| Software version | (8012) | Defined field | Not typical |
Which PI elements are mandatory is set by the regulator, not the agency. Under the FDA rule the label must carry the PI elements that appear on it (lot, serial, expiry, manufacturing date as applicable); the EU MDR requires the elements relevant to the device class and Annex VI. The agency only defines the syntax.
3. Barcodes and readability
- GS1: GS1-128 (linear) or GS1 DataMatrix (2D). DataMatrix is standard for small devices, instruments and direct part marking; GS1-128 for cartons and shipping units. FNC1 must lead the string.
- HIBCC: Code 128 or DataMatrix carrying the HIBC primary and secondary structures, concatenated with
/. - ICCBBA: Code 128 (ISBT 128 flavour) or DataMatrix.
- IFA: DataMatrix carrying the PPN with defined data identifiers.
Every label must also show the human-readable interpretation (HRI) of the UDI next to the barcode, and the barcode must verify at the required grade (ISO/IEC 15415/15416, typically grade C or better in practice). Print size and quiet zones matter more than most people expect; a DataMatrix printed at 0.25 mm module on thermal-transfer with a wax ribbon rarely verifies.
4. Choosing
- Do you already hold a GS1 company prefix? Then GS1 — you avoid a second numbering system and your distributors already scan GTINs.
- Healthcare-only, many SKUs, want a fixed fee? HIBCC.
- Blood, tissue, cell or milk products? ICCBBA is the purpose-built system.
- German/Austrian company already using PZN, EU-only? IFA PPN is convenient — but it is not FDA-accredited, so US sales need GS1 or HIBCC.
- Check the preference of your largest customers and GPOs before deciding; a hospital that runs a GS1-only scanning workflow will push you to GS1 regardless of what the regulation allows.
5. From choice to label
- Register with the agency and obtain your prefix / LIC / FIN.
- Assign a DI per device model and packaging level; register it in GUDID (FDA) and/or EUDAMED (EU).
- Build the PI string at packaging time from the batch record.
- Encode as DataMatrix or GS1-128, print with HRI, verify the grade.
- Apply the label to the device or its packaging as required by the regulation; add direct part marking where the device is reusable.
Build a GS1 UDI and its barcode online
Enter GTIN, lot, serial and expiry; the generator assembles the AI string and renders GS1 DataMatrix or GS1-128 with the human-readable line. Open the tool →
References
This article is based on the following primary sources; always check the edition in force before shipping or labelling.
- US FDA — Unique Device Identification System (UDI System)
- European Commission — Unique Device Identifier (UDI) under MDR/IVDR
- GS1 — UDI implementation resources
- GS1 — General Specifications (barcode symbol and identification key rules)
- GS1 — Barcodes overview (EAN/UPC, GS1-128, ITF-14, DataMatrix)
- ISO/IEC 15417 — Code 128 bar code symbology specification
- ISO/IEC 15420 — EAN/UPC bar code symbology specification
Frequently asked questions
Which UDI issuing agencies are accepted by the FDA and in the EU?
The FDA has accredited three: GS1, HIBCC and ICCBBA. The European Commission has designated four issuing entities for MDR/IVDR: GS1, HIBCC, ICCBBA and IFA GmbH (the German PPN system). A device sold in both markets normally uses one of the three common agencies so that a single UDI serves both.
What is the difference between UDI-DI and UDI-PI?
The Device Identifier (DI) is the static part that identifies the labeller and the specific version or model of the device — it is what you register in the FDA GUDID or EUDAMED. The Production Identifier (PI) is the variable part: lot or batch, serial number, manufacturing date, expiry date, and for some devices the software version. The DI is mandatory on every label; which PI elements appear depends on the device and its risk class.
Should I use GS1 or HIBCC?
GS1 if your devices also move through general retail or hospital supply chains that already scan GTINs, if you want the widest global recognition, or if you already hold a GS1 company prefix. HIBCC if you are a healthcare-only manufacturer who wants a fixed annual fee independent of the number of products and prefers the alphanumeric HIBC structure. Both are accepted by the FDA and under EU MDR; distributors and GPOs sometimes state a preference.
Which barcode should I print for UDI?
The choice belongs to the manufacturer but must be one the issuing agency's system supports: GS1-128 or GS1 DataMatrix for GS1 (DataMatrix is the usual choice for small devices and direct part marking); Code 128 or DataMatrix carrying HIBC data for HIBCC; ISBT 128 Code 128 or DataMatrix for ICCBBA; DataMatrix for IFA PPN. The human-readable interpretation must be printed alongside the barcode.