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Unique Device Identification (UDI) FAQ

 

“UDI” stands for Unique Device Identification, basically, a way for every medical device to have its own clear identity instead of relying on “the blue box on shelf three.” Regulators introduced UDI to improve patient safety, make recalls faster and more accurate, strengthen traceability, and help healthcare systems keep better track of devices throughout the supply chain. In Australia, the TGA officially launched the Australian UDI framework, with mandatory requirements starting from 1 July 2026 for high-risk medical devices.

If it’s a medical device, there’s a good chance you’ll need a UDI. That includes implantable devices, reusable devices, and even software-based medical devices. There are some exceptions for things like custom-made or investigational devices, depending on classification and regulatory rules, so it’s worth checking the fine print before assuming you’re off the hook.

For GS1 members, you will already have a GS1 Company Prefix, which uniquely identifies your business globally. You may also be assigning GTINs to your devices, and encoding them in a barcode. The GTIN is your UDI-DI Device Identifier, the first part of the UDI. The second part is the UDI-PI Production Identifier, which can include things like batch number, serial number, manufacturing date, or expiry date. Every product variation and packaging level needs its own unique UDI for traceability in the supply chain from manufacturer to the patient that receives the device.

A UDI has two main parts:

  • The Device Identifier (UDI -DI), which identifies the manufacturer and specific device model.

  • The Production Identifier (UDI-PI), which can include batch numbers, serial numbers, manufacturing dates, or expiry dates.

The UDI-PI details included depend on the manufacturer and regulatory requirements. The UDI appears both as readable text and as a scannable barcode, usually something like a GS1 DataMatrix or GS1-128 barcode — because healthcare really does love an acronym and a barcode.

It depends a bit on the product and packaging — there’s no one-size-fits-all barcode.

GS1 DataMatrix is commonly used for smaller healthcare products and direct part marking, while GS1-128 is often used for cartons and logistics packaging.

EAN-13 may still apply for retail medical devices. Choosing the right barcode usually comes down to label space, packaging level, and regulatory requirements

The core UDI principles are aligned globally, but implementation specifics do vary by region.

The FDA uses the GUDID database, the EU uses EUDAMED and includes the Basic UDI-DI requirement, and Australia’s TGA framework is being introduced progressively as of 1 July 2026 onward.

Most global manufacturers aim for one harmonised approach that can work across multiple jurisdictions, and GS1 GTIN’s are widely recognised across all of these systems.

Manufacturers typically submit details like the Device Identifier, brand and model information, risk classification, packaging hierarchy, sterility status, configuration details, and regulatory status.

A lot of companies start with “we just need a barcode,” and then quickly realise UDI touches almost every part of the business. Common challenges include updating labels and packaging artwork, improving master data quality, aligning ERP and regulatory systems, managing global requirements, and making sure barcodes actually scan properly in the real world. It’s part regulatory project, part data project.

The best approach is to start early! Manufacturers should review the regulations for each market they supply into, assess their current product and packaging data, assign compliant GS1 identifiers like GTINs, choose the right barcode carriers, and establish strong data governance processes. Testing barcode quality and training internal teams early can save a lot of headaches later. Organisations that get the most with UDI are usually the ones treating it as a business improvement project, not just a compliance exercise!