UDI for medical devices: structure, FDA and EU MDR requirements, and how to print it

Device Identifier vs Production Identifier, issuing agencies, GUDID and EUDAMED, barcode formats and direct marking — everything a label must carry.

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Unique Device Identification gives every medical device a code that can be read by people and machines, from manufacturer to patient. The United States (FDA, 21 CFR Parts 801 and 830) and the European Union (Regulations 2017/745 MDR and 2017/746 IVDR) built their systems on the same international model, so one label design can serve both — if it carries the right pieces in the right form.

The two halves of a UDI

Device Identifier (UDI-DI): a fixed code for a specific version or model from a specific labeler. It is the key into the public databases.
Production Identifier (UDI-PI): the variable part — lot or batch, serial number, expiration date, manufacturing date, and for human cells and tissues the distinct identification code. Which PIs apply depends on what the label already controls.

The EU adds a third concept, the Basic UDI-DI: a grouping identifier for devices with the same intended purpose, risk class and essential design, used in certificates and the declaration of conformity but not printed on the label.

Issuing agencies and formats

UDIs are assigned under the rules of an accredited issuing agency. The FDA accredits GS1, HIBCC and ICCBBA; the EU designates the same three plus IFA (for the German PPN). With GS1, the UDI-DI is a GTIN and the PIs are Application Identifiers: (01) GTIN, (17) expiration, (10) lot, (21) serial, (11) manufacturing date. HIBCC uses its own primary/secondary data structure.

What the label must show

The UDI in AIDC form (a barcode: GS1-128 or, more often, GS1 DataMatrix because of the space) and in human-readable interpretation (HRI) directly beneath or beside it.
The same data on every package level that is a unit of use or sale, each with its own UDI-DI.
Direct marking on the device itself for reusable devices that are reprocessed between uses (FDA) and for reusable devices in the EU, unless technically impossible.
Print quality verified to ISO/IEC 15415 for 2D codes; grade requirements are set by the issuing agency (GS1 requires grade 1.5/C or better for DataMatrix).

Databases and timelines

In the US, the labeler submits the UDI-DI and device attributes to GUDID before marketing. In the EU, UDI data goes to EUDAMED. FDA compliance was phased by risk class between 2014 and 2022 and is complete. Under the MDR, the UDI carrier became mandatory on labels of Class III and implantable devices in May 2021, Class IIa/IIb in May 2023 and Class I in May 2025; IVDR follows a staggered schedule through 2027 for the lower classes. Reusable devices requiring direct marking have two additional years in each case.

Common mistakes

Encoding the expiration date in a format other than YYMMDD in AI (17), or printing a different date in the HRI than in the barcode.
Reusing a serial number within a lot, or resetting counters when a template is copied to another plant.
Changing a device attribute (sterile/non-sterile, packaging quantity) without assigning a new UDI-DI.
Scaling the DataMatrix so its module falls between printer dots; at 300 dpi keep the module at whole-dot multiples.

How EtikStudio handles this

UDI templates generate the GS1 DataMatrix or GS1-128 with the correct AI syntax and the HRI from the same data, so the two can never diverge. Serial counters are unique per lot across the organization, dates are formatted for the AI automatically, and each print run is recorded with template version, printer and operator — the traceability record notified bodies and the FDA expect.

Questa guida è informativa e non costituisce consulenza legale. Le normative cambiano; verifica sempre il testo ufficiale vigente prima di stampare.