How to Create Medical Device Labels? A Detailed Explanation of UDI Unique Device Identification Coding Rules

Last week, a client exporting medical dressings asked me:

"My U.S. customer is asking me to mark UDI, but I don't understand what UDI is—how is it different from a GS1 barcode?"

I said: UDI is like an express tracking number—every medical device has a globally unique 'ID number'. The GS1 barcode is the physical carrier of the waybill, while UDI is the encoding rule behind it.

Medical device labels are completely different from labels in other industries—they are governed by a strict regulatory system (UDI, ISO 15223, CE MDR, FDA CFR). Non-compliance = recall + fines + market ban.

This article explains the regulatory map for medical device labels.

What is UDI?

UDI (Unique Device Identification): A globally unique identification code for every medical device, mandatorily enforced by the FDA in 2013, implemented in phases starting in 2018, and covering all medical devices from 2022 onward.

Two-Level UDI Structure

UDI = DI (Device Identifier)
    + PI (Production Identifier)

• DI: Device model, brand, and specifications. Permanently unchanging.
• PI: Batch number, production date, expiry date, and serial number. Unique to each product.

Example: UDI = (01) 12345678901234 + (17) 250101 + (10) AB123

• (01) is the DI: device model
• (17) 250101 is the PI: expiry date 2025-01-01
• (10) AB123 is the PI: batch number

Physical Carriers of UDI

UDI codes must be printed on labels, and there are 4 types of physical carriers:

1. GS1-128 Barcode (1D barcode) — mainstream carrier, fast scanning
2. GS1 DataMatrix (2D code) — small size, suitable for medical devices
3. RFID Tag (passive) — strong traceability
4. Plain-Text UDI (human-readable) — essential backup

Practical Selection: 90% of medical devices use the GS1 DataMatrix + plain-text dual-carrier combination.

Map of the 3 Major Regulatory Systems

Medical device labeling is divided into three major regulatory systems globally:

Regulation 1: US FDA 21 CFR 820 + UDI Regulation

Applicable to: All medical devices entering the US market.

Core requirements:

• UDI labels must be clear and legible
• DI must be included in the FDA's GUDID database
• Production date and expiration date in PI must use the GS1 standard format
• UDI must be affixed to both the minimum sales unit and the unit of use

Compliance deadline: From September 2022, all FDA-registered medical devices must comply with UDI.

Regulation 2: EU CE MDR 2017/745

Applicable to: All medical devices entering the EU market.

Core requirements:

• UDI must comply with the EU UDI database (EUDAMED)
• Two-tier coding: Basic UDI-DI (model level) + UDI-DI (product level)
• Device labels must include the CE mark
• EU Authorized Representative information must be provided
• Must comply with ISO 15223-1 symbol standards

Note: CE MDR 2017/745 was mandatorily implemented in May 2021, replacing the old MDD 93/42/EEC.

Regulation 3: ISO 15223-1 Symbol Standard

Applicable to: Universal symbols for medical devices globally.

Core symbols (must appear on the label):

• 📅 Date of manufacture (hourglass symbol)
• 📆 Expiration date (hourglass + prohibition symbol)
• 📦 Batch code (LOT marking)
• 🔢 Serial number (SN marking)
• 📋 Consult instructions for use
• ⚠️ Caution / warning
• 🧊 Storage temperature
• ☂️ Keep away from light and moisture
• ♻️ Recycling

Benefit: Using symbols instead of multilingual text saves label space.

Differences in UDI Under Different Regulations

5 Steps for UDI Coding Implementation

1. Register a GS1 Company Prefix——Each company must apply for a 7-12 digit company prefix from GS1
2. Assign DI Numbers——One DI per model
3. Assign PI Numbers——One PI per production unit
4. Label Printing——UDI code + required symbols + multilingual text
5. Database Registration——DI information entered into FDA GUDID / EU EUDAMED

To learn about the compliance process, refer to How to Choose Food Packaging Boxes? GB 4806 Compliance Checklist, or directly contact a LeXiang Packaging consultant, and you will receive a UDI solution + regulatory compliance checklist within 24 hours.