The Four Designated Entities
MDR Article 27 and IVDR Article 24 each set up a UDI system. Under paragraph 3 of each article, the manufacturer assigns a UDI created under the rules of a Commission-designated issuing entity before placing a device on the market, other than a custom-made device under the MDR and other than a device for performance study under the IVDR. The Commission does the designating by implementing act, against criteria that paragraph 2 of each article lays down for who may qualify as an issuing entity.
Commission Implementing Decision (EU) 2019/939 designated four entities against those criteria: GS1 AISBL, the Health Industry Business Communications Council (HIBCC), ICCBBA, and Informationsstelle für Arzneispezialitäten, IFA GmbH. The original designation ran for five years from 27 June 2019. Commission Implementing Decision (EU) 2024/2120 renewed all four, for a further five years, from 27 June 2024 until 27 June 2029, after the Commission confirmed each entity still met the designation criteria.
What Each One Actually Is
Each of the four runs a coding system built for a different industry. Which one a manufacturer already works with, if any, follows from that.
GS1
GS1 is the standards body behind the barcode used across retail and general supply chains worldwide, including the Global Trade Item Number (GTIN). A manufacturer that already licenses a GS1 Company Prefix for other product lines can use the same prefix to start its first UDI assignment, because a GS1 Basic UDI-DI (the Global Model Number) starts with it and every GTIN under it contains it.
HIBCC
The Health Industry Business Communications Council runs the Health Industry Bar Code (HIBC) standard. HIBCC was founded in 1983, and the mandate to develop the HIBC standard grew out of a task force hosted by the American Hospital Association. It is recognized as a UDI issuing agency in the United States as well as the EU. A manufacturer already shipping into US healthcare distribution under HIBC codes already holds a HIBCC Labeler Identification Code, which is also the second element of a HIBC Basic UDI-DI, so it can stay with HIBCC instead of opening a second relationship with a different entity.
ICCBBA
ICCBBA manages ISBT 128, a coding standard built for medical products of human origin: blood, cells, tissues, human milk, and organs. ICCBBA's own medical devices page says traditional medical devices fall outside the scope of ISBT 128. The device case it describes is a human-origin product, such as a tissue tendon or bone putty, attached to a non-human element, such as a suture or a syringe applicator, which a regulator may treat as a medical device.
IFA
IFA GmbH (Informationsstelle für Arzneispezialitäten) allocates the German Pharmazentralnummer (PZN), the product number for medicines and pharmacy products in Germany, and as a UDI issuing entity it issues the Pharmacy Product Number (PPN) as UDI-DI. A manufacturer already supplying that channel, for example a device routinely dispensed through German pharmacies, has an existing operational reason to code through IFA rather than open a new relationship elsewhere.
Format at a Glance
The EUDAMED Playground help page on Basic UDI-DI generatorslays out the Basic UDI-DI structure for each issuing entity. All four end in a two-character check element that the issuing entity's own algorithm defines, and each carries a manufacturer, labeler, or facility identifier followed by a model or product code. Only HIBCC and IFA open with a fixed flag.
| Entity | Standard | How a code reads | Check digit |
|---|---|---|---|
| GS1 | Global Model Number (GMN) | Numeric GS1 Company Prefix, then a model reference that may contain letters; up to 25 characters | Two check characters |
| HIBCC | HIBC | Opens with a fixed ++ flag, then a 4-character Labeler Identification Code and a model identifier of 1 to 17 characters | Two check characters (Mod 1021 and Mod 32) |
| ICCBBA | ISBT 128 | Four alphanumeric elements: a 5-character facility identifier, a 6-character product code, a 5-character product description code and the check element | Two-character check element |
| IFA | IFA Coding System | Opens with a fixed PP issuing-agency code, then a 5-digit manufacturer code and a device group code of 1 to 16 characters | Two check digits, Modulo 97 |
Does EUDAMED Treat Them Differently?
No. EUDAMED's UDI/Devices data dictionary accepts GS1, HIBCC, ICCBBA, or IFA as the value of the Issuing Entity field with no preference among them, and (for a legacy device's EUDAMED DI only) EUDAMED itself as a fifth, separate value. No entity is preferred. Each code must follow the structure of the entity named in the field, which is what the per-entity formats in the previous section describe.
Issuing Entity Basic UDI-DI and Issuing Entity UDI-DI are two separate fields in the data dictionary, set independently. Each code must be valid within its own issuing entity's system, and each UDI-DI still links to exactly one Basic UDI-DI, the relationship MDCG 2018-1 Rev.4 describes.
How to Choose
All four are legally equivalent, so the decision comes down to what already exists in your business.
- Already a GS1 member for other product lines? Extend that membership to your medical devices rather than opening a second relationship.
- Already shipping into the US under HIBC codes? HIBCC lets you keep one coding relationship across both markets instead of running GS1 for the EU and HIBC for the US in parallel.
- Device combines a human-origin component with a non-human one? Check whether ICCBBA's ISBT 128 standard fits the product before picking another entity. A human-origin product attached to a non-human element is the device case ICCBBA describes.
- Selling primarily through German pharmacy and wholesale channels? IFA already allocates the PZN those channels use, and it issues the PPN as UDI-DI.
- Starting from nothing, with no existing membership anywhere? Then it is a business decision about fees, tooling, and which standard your distributors already scan. The regulation expresses no preference.
Common Confusions
| Confusion | What Is Actually True |
|---|---|
| "GS1 is the official EU standard; the others are alternatives" | All four were designated by the same Commission decision under the same criteria, and the 2024 renewal covered all four for the same period. |
| "ICCBBA is only for blood banks, not manufacturers" | The Commission's designation puts no restriction on who may use ICCBBA. ICCBBA's own scope statement is about product type: ISBT 128 is for products of human origin, and its device case is a human-origin product combined with a non-human element. |
| "Once you pick an issuing entity, every UDI on the device uses it" | Issuing Entity Basic UDI-DI and Issuing Entity UDI-DI are set separately, and the data dictionary has a Secondary UDI-DI field for a second DI issued by a different entity. |
Relevant Guidance
| Document | Topic | Key Content Used Here |
|---|---|---|
| Commission Implementing Decision (EU) 2019/939 (6 June 2019) | Designation of UDI issuing entities | Names the four designated entities and sets the original five-year validity period |
| Commission Implementing Decision (EU) 2024/2120 (30 July 2024) | Renewal of the designation | Renews all four designations from 27 June 2024 to 27 June 2029 |
| MDR Article 27 / IVDR Article 24 | Legal basis for the UDI system and the designation criteria | Statutory UDI-DI definition and the entity-designation criteria in paragraph 2 of each article |
| MDR Annex VI Part C | Regulatory text for the UDI system | Basic UDI-DI definition (Section 1) and the rule that only designated issuing entities' coding standards may be used (Section 2.4) |
The regulation does not care which of the four you pick. It does care that each code you submit is valid within that entity's system, that the Basic UDI-DI and UDI-DI are kept apart, and that the issuing entity field on every record names the entity that actually issued the code.
Frequently Asked Questions
Is GS1 legally required for UDI assignment in the EU?
No. The European Commission designated four issuing entities, GS1 AISBL, HIBCC, ICCBBA, and IFA GmbH, under Commission Implementing Decision (EU) 2019/939, and none of them is given legal priority over the others. The regulation gives a code from HIBCC, ICCBBA, or IFA the same legal standing as a GS1 code.
Who currently designates and renews the four UDI issuing entities, and until when?
The European Commission, acting under MDR Article 27, paragraph 2, and IVDR Article 24, paragraph 2. Commission Implementing Decision (EU) 2019/939 made the original five-year designation from 27 June 2019. Commission Implementing Decision (EU) 2024/2120 renewed all four designations for a further five years, from 27 June 2024 until 27 June 2029.
Are the issuing entity of a Basic UDI-DI and of its UDI-DI entered separately?
Yes. Issuing Entity Basic UDI-DI and Issuing Entity UDI-DI are separate data elements in the EUDAMED UDI/Devices data dictionary, each independently set to one of GS1, HIBCC, ICCBBA, or IFA (or EUDAMED itself for a legacy device's EUDAMED DI).
Is ICCBBA legally restricted to blood and tissue products under MDR and IVDR?
No. Commission Implementing Decision (EU) 2019/939 designates ICCBBA for the same scope as the other three entities, with no product-category condition written into the designation itself. The restriction is ICCBBA's own: its ISBT 128 standard is built for products of human origin, and ICCBBA's own medical devices page states that traditional medical devices fall outside the scope of ISBT 128. That is a scope statement by ICCBBA, not a legal limit imposed by the designation.
What happens to the UDI-DI when a manufacturer switches issuing entity?
A UDI-DI is a code issued within one entity's coding system, and a code from a different entity is a different code, so the new entity issues a new UDI-DI. The regulation's own trigger list for a new UDI-DI, MDR Annex VI Part C, Section 3.9, covers data changes such as name, model or pack quantity and does not address the issuing entity.