UDI Requirements for Medical Devices in Europe — EU MDR Complete Guide

The Unique Device Identification (UDI) system is one of the most significant operational changes introduced by EU MDR. Every medical device placed on the EU market must carry a UDI.

What is a UDI?

A UDI has two components:

• UDI-DI (Device Identifier) — the static part identifying the specific version or model. Must be registered in EUDAMED before the device goes on market.
• UDI-PI (Production Identifier) — the dynamic part identifying the specific unit, including lot number, serial number, manufacturing date, or expiry date.

UDI carrier formats

• GS1 DataMatrix 2D barcode — most commonly used, compact and accepted by all EU health systems
• 1D barcodes — GS1-128, HIBC LIC, or ISBT 128 formats
• RFID — required for active implantable devices

UDI deadlines by device class

• Class III and implantable Class IIb — from May 2021
• Class IIa and non-implantable Class IIb — from May 2023
• Class I devices — from May 2025
• Reusable surgical instruments — from May 2027

How to register your UDI in EUDAMED

UDI-DI registration in EUDAMED is mandatory before any device goes on the EU market. The process:

• Step 1 — Obtain a UDI issuing agency account. Choose GS1, HIBCC, or ICCBBA. GS1 is the most common for EU medical devices.
• Step 2 — Assign your UDI-DI. The Device Identifier must be unique per device version or model. Any change that makes two devices not interchangeable requires a new UDI-DI.
• Step 3 — Register in EUDAMED Basic UDI-DI module. Submit device description, intended purpose, risk class, sterility status, and GMDN code.
• Step 4 — Apply UDI carrier to the label. GS1 DataMatrix 2D barcode plus Human Readable Interpretation text. Both must appear on the device label before market placement.
• Step 5 — Maintain and update. Any device change requiring a new UDI-DI must be updated in EUDAMED before the updated device ships.

UDI-DI vs UDI-PI — what is the difference?

The UDI-DI (Device Identifier) identifies the specific model or version — it is the same for every unit of that model. The UDI-PI (Production Identifier) identifies the specific unit produced, including lot/batch number, serial number, manufacturing date, and expiry date. Only the UDI-DI must be registered in EUDAMED. The UDI-PI appears on the label but is not submitted to the database.

Common UDI mistakes

• Using FDA UDI numbers directly — EU and FDA use different formats
• Not updating UDI-DI after device changes
• Missing Human Readable Interpretation text below the barcode
• Incorrect EUDAMED data submissions

Contact NordMDR AB for a free UDI compliance assessment.