What is the UDI Carrier?

The UDI (Unique Device Identifier) Carrier is the part of a medical device label that shows the UDI information. It's what gets printed (or engraved) on the product, packaging, or documentation, usually as text and a barcode.

Why is the UDI Carrier Important?

The EU wants to make sure that every medical device can be:

• Identified easily

• Traced quickly if there's a problem

• Linked to safety information in EUDAMED (the European medical device database)

That’s why UDI carriers are mandatory under the EU MDR.

What Needs to Be on the Label (UDI Carrier)?

There are 2 parts to a UDI:

1. UDI-DI – Device Identifier (the product’s ID, stays the same)

2. UDI-PI – Production Identifier (variable info like LOT, SN, expiry, etc.)

The UDI Carrier must include:

Format	What it includes
Human-readable	UDI-DI and UDI-PI in plain text
Machine-readable	Barcode (e.g. GS1-128, GS1 DataMatrix)

Where Should the UDI Carrier Be Placed?

It depends on the type of packaging:

Packaging Level	Label Required?
Device itself	Yes (if space allows)
Primary packaging (e.g., a blister pack)	Yes
Secondary packaging (e.g., cardboard box)	Yes

If there's no room on the device, you can just label the packaging.

When Is It Required?

The EU MDR timeline for UDI labeling started in 2021, and it’s being rolled out step by step:

Device Class	Deadline for UDI on label
Class III (high risk)	May 26, 2021
Class IIa / IIb	May 26, 2023
Class I (low risk)	May 26, 2025

For reusable devices, UDI must also be directly marked on the product (e.g., engraved or etched), not just on the packaging.

Example

Imagine you're selling a thermometer:

• UDI-DI: 12345678901234

• UDI-PI: Lot 98765, Expiry 2026-12

Your label should include:

• Text: (01)12345678901234 (10)98765 (17)261231

• Barcode: GS1-compliant code showing the same info

Summary Checklist

•  Label must show both UDI-DI and UDI-PI

•  Use both text and barcode (or 2D code)

•  Place on product, primary, and secondary packaging

•  Follow deadlines based on device class

•  Direct marking if device is reusable