UDI Carrier Requirements for Class I Medical Devices: What to Know Before the 26 May 2025 Deadline

Marcel Akiyama
16 mai 2025
3 min de lecture

Dernière mise à jour : 10 déc. 2025

Under the European Union’s Medical Device Regulation (MDR 2017/745), the implementation of the Unique Device Identification (UDI) system is a cornerstone of enhanced traceability, post-market surveillance, and patient safety. For Class I medical device manufacturers, the final compliance deadline for UDI carrier (label) requirements is 26 May 2025.

This article provides a detailed guide to what is required, how to prepare, and how to remain compliant with EU MDR labeling obligations for Class I devices.

What Is the UDI Carrier?

The UDI carrier is the means by which the UDI is conveyed on the label or packaging of a medical device. It consists of two parts:

UDI-DI (Device Identifier): A fixed identifier that relates to the specific version or model of the device, including manufacturer information.
UDI-PI (Production Identifier): A variable component that includes data such as the lot number, serial number, manufacture date, and expiration date.

The UDI carrier must appear on the product label in both:

Human-readable format (plain text)
Machine-readable format (usually a barcode or 2D DataMatrix)

Compliance Deadline for Class I Devices

The EU MDR outlines a staggered implementation of UDI requirements depending on the device class. For Class I medical devices, the deadline to place the UDI carrier on the label is 26 May 2025.

From this date forward, any Class I device placed on the EU market must be labeled with a UDI-compliant identifier and barcode, unless it qualifies under specific transitional provisions.

What Must Be on the Label?

The following information must be included on the device’s label or its packaging:

UDI-DI (Device Identifier)
UDI-PI (Production Identifier) – This may include:
- Lot or batch number
- Serial number
- Expiry date (mandatory if applicable)
- Manufacture date (required if there is no expiry date)
Format:
- Textual (human-readable)
- Barcode (machine-readable) using a format such as GS1-128, GS1 DataMatrix

Example Label Information Human-readable: (01) 09504000059118 (10) A12345 (17) 260501

Machine-readable: [Barcode displaying the same information above, typically in GS1-128 or GS1 DataMatrix format] Note: The numbers in parentheses are GS1 Application Identifiers: (01) = GTIN, (10) = Batch/Lot, (17) = Expiry Date

Where Must the UDI Be Placed?

The MDR requires the UDI carrier to appear:

On the label of the device itself, or
On all higher levels of packaging (i.e., primary and secondary packaging)

The UDI does not need to appear on shipping containers unless they also serve as secondary packaging.

Steps to Achieve Compliance

To meet the 26 May 2025 deadline, Class I device manufacturers should take the following steps:

1. Assign UDI-DIs and UDI-PIs

Work with an EU-accredited UDI-issuing agency such as GS1, ICCBBA, or HIBCC.
Obtain a GS1 company prefix and use it to generate GTINs, which serve as the UDI-DIs.

2. Update Labeling Systems

Ensure your labeling software and packaging processes can handle both human-readable and barcode formats.
Confirm correct application of GS1 application identifiers and formatting guidelines.

3. Prepare Technical Documentation

Maintain a UDI assignment record and document how UDI-DIs are linked to device versions, models, and packaging configurations.
Include UDI data in the device’s technical documentation and Declaration of Conformity.

4. Register UDIs in EUDAMED

Once EUDAMED becomes fully functional and mandatory, manufacturers must upload UDI-DI and related device data into the UDI/Device Registration module.
Class I manufacturers are encouraged to begin this process voluntarily, as several modules are already operational.

5. Train Teams and Ensure Quality Control

Provide training to regulatory, manufacturing, and quality teams on UDI generation, labeling, and data management.
Implement robust quality checks to validate barcode readability and data accuracy.

Penalties for Non-Compliance

After 26 May 2025, Class I devices without compliant UDI carriers will not be allowed on the EU market. Competent authorities may:

Reject or seize non-compliant products
Issue fines or suspend CE certificates (if applicable)
Trigger market recalls or enforcement actions

Final Thoughts

The UDI system is a central element of the MDR’s vision for safer, more transparent medical device regulation. For Class I manufacturers, the 26 May 2025 UDI labeling deadline marks a key regulatory milestone. Preparing now by aligning labeling, production, and documentation practices will ensure both compliance and market continuity.