QR & Barcode StudioQR Studio

UDI Barcodes for Medical Devices

A Unique Device Identification (UDI) barcode identifies a medical device and its production details so it can be traced through the supply chain and to the patient. Under FDA and EU MDR rules it must be shown in both machine-readable and human-readable form, and GS1 DataMatrix is the most common carrier.

Create it now

What a UDI contains

A UDI has two parts. The device identifier (UDI-DI) is fixed per model and packaging level; with GS1 it is a GTIN under AI (01). The production identifier (UDI-PI) varies per unit and may include AI (17) expiry date as YYMMDD, AI (10) batch or lot and AI (21) serial number, plus (11) manufacturing date where relevant. An example reads (01)09506000134352(17)271231(10)A123(21)0001.

Regulatory context

  • In the United States, the FDA UDI rule applies, and device data is submitted to the GUDID database.
  • In the EU, the MDR and IVDR require UDI on devices, with data registered in EUDAMED.
  • GS1 is one of the accredited issuing agencies; HIBCC and ICCBBA are others with their own formats.
  • Requirements depend on device class and timelines, so confirm the details with your regulatory team or notified body.

Getting the data right

GS1 DataMatrix starts with the FNC1 character that marks GS1 data, and variable-length fields such as lot and serial need a separator before the next AI, unless they come last. Dates must be valid, and the GTIN check digit must match. The barcode tool parses the AIs as you type, checks lengths and check digits, and warns when an expiry date is already in the past.

This tool helps with drawing and data checks; formal print-quality grading to ISO/IEC 15415 requires a verifier.

How to make it

  1. Open Barcode and choose GS1 DataMatrix.
  2. Enter the UDI string with AIs in brackets, for example (01), (17), (10) and (21).
  3. Fix any errors shown for length, check digit or date.
  4. Export as SVG or PDF for your label artwork and include the human-readable text.

Frequently asked questions

Is a GS1 DataMatrix required for UDI?

The rules require automatic identification and data capture technology, not one specific symbol. GS1 DataMatrix and GS1-128 are both widely used; DataMatrix is popular because it is small.

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

UDI-DI identifies the device model and package level and does not change per unit. UDI-PI holds variable data such as lot, serial number and expiry date.

Can I use this barcode on a regulated device label?

You can draw and check the symbol here, but your quality system remains responsible for validating label content and print quality against the applicable regulations.