What’s the Difference Between UDI-DI and Basic UDI-DI and Which One Goes on the Label?

If you're working toward EU MDR compliance, you've probably come across the terms UDI-DI and Basic UDI-DI. While they sound similar, they serve very different purposes — and confusing them can lead to serious compliance issues.

In this post, we’ll explain the difference between the two, and clarify which one must appear on your product label.

What Is UDI-DI?

UDI-DI stands for Unique Device Identifier – Device Identifier. It's the specific part of the UDI that identifies the exact version or model of a medical device.

Think of it as the fingerprint of that product.

• It's product-specific

• Assigned by the manufacturer, typically using a GS1 GTIN (Global Trade Item Number)

• Must appear on the label and packaging

• Is encoded in both machine-readable (e.g. DataMatrix) and human-readable text (HRI)

• Is required during UDI registration in EUDAMED

Example:If you manufacture a glucose meter model "GlucoLite 2000", the UDI-DI refers specifically to that model, and must appear on the product label.

What Is Basic UDI-DI?

The Basic UDI-DI is a reference identifier that connects related devices under a shared intended purpose, risk class, and design.

Unlike the UDI-DI, the Basic UDI-DI is not printed on the product.

• It's not device-specific, but rather device-family-specific

• Required for regulatory processes such as CE certification, technical documentation, and vigilance reporting

• Must be submitted to EUDAMED, but not used on physical labeling

Example:“GlucoLite 2000”, “GlucoLite 2000 Plus”, and “GlucoLite 2000 Mini” might all share the same Basic UDI-DI, even though each version has its own UDI-DI.

Which One Goes on the Label?

Only the UDI-DI should appear on the label.

Your UDI label — including the barcode and human-readable text — must include:

• The UDI-DI (often in GTIN format)

• The UDI-PI (production identifiers such as lot number, serial number, expiration date)

The Basic UDI-DI is for regulatory documentation only, not for printing or packaging.

How EasyUDI Handles It

EasyUDI ensures your labeling process is both accurate and compliant:

• It embeds your GTIN (UDI-DI) into the DataMatrix barcode and HRI automatically

• It includes UDI-PI data such as lot number, serial number, and expiration date

• It stores the Basic UDI-DI for EUDAMED or CE documentation use, but does not print it on labels

• It validates your data and helps prevent common errors before they reach production
  

Quick Recap

Feature	UDI-DI	Basic UDI-DI
Appears on the label	Yes	No
Device-specific	Yes	No
Required in EUDAMED	Yes	Yes
Used in barcodes	Yes (DataMatrix + HRI)	No

Final Thoughts

If you're preparing for EU MDR compliance, make sure you’re putting the correct identifier on your label, the UDI-DI. Mislabeling with a Basic UDI-DI can result in regulatory setbacks, failed audits, and costly delays.

Need help generating compliant UDI labels?

Book a free demo with EasyUDI and simplify your path to full MDR compliance, before the 26 May 2025 deadline.