How Class I Medical Device Manufacturers Can Register with GS1 and Obtain GTINs

Marcel Akiyama
16 mai 2025
3 min de lecture

As a Class I medical device manufacturer operating in the European Union, meeting regulatory requirements such as those set by the Medical Device Regulation (MDR 2017/745) is essential. One key requirement is assigning Unique Device Identifiers (UDIs) to your products. This process often begins with obtaining GTINs through GS1, one of the accredited UDI issuing agencies.

This guide walks you through the step-by-step process of registering with GS1 and getting GTINs for your Class I medical devices.

What Is a GTIN and Why Is It Important?

GTIN (Global Trade Item Number) is a unique identifier for trade items developed by GS1, used globally to track and trace products. For medical devices, GTIN is used as the Device Identifier (DI) portion of the UDI.

Why You Need GTINs:

Required for UDI labeling under EU MDR.
Mandatory for registration in EUDAMED.
Ensures traceability, safety, and market access.

Step-by-Step Guide to Register and Get GTINs

Step 1: Understand Your Regulatory Scope

Before starting, confirm that:

Your product is classified as Class I under EU MDR.
You are either the manufacturer or authorized representative responsible for labeling and registration.

Step 2: Register with Your Local GS1 Member Organization

GS1 operates through local offices in each country (e.g., GS1 UK, GS1 France, GS1 US, etc.). Start by locating your local GS1 organization:

What You’ll Need:

Company legal information.
Business registration documents.
Product information (general categories, quantity).

Step 3: License a GS1 Company Prefix

When you register, you will purchase a GS1 Company Prefix—a unique number assigned to your company. This prefix allows you to create GTINs for multiple products.

The length of your prefix determines how many GTINs you can generate.
Pricing is usually based on company size or turnover.

Step 4: Create GTINs for Your Devices

Once you have your prefix, use GS1 tools to generate GTINs:

Options:

GS1’s GTIN Generator (varies by country)
Manual assignment using GS1 standards

Each medical device (including packaging variations) should have a unique GTIN.

Example GTIN structure (simplified):

[GS1 Prefix] + [Item Reference] + [Check Digit]

Step 5: Assign GTINs to Each Product Configuration

For each device version or model, assign a unique GTIN. You’ll need GTINs for:

Individual units
Multipacks (if applicable)
Different sizes or configurations

✅ Best Practices:

Keep a GTIN log or product catalog.
Map GTINs to internal SKUs or item codes.

Step 6: Label Your Devices with the UDI (Including GTIN)

Your GTIN becomes part of the UDI on the product label. You must follow GS1 guidelines for:

Barcode format (usually GS1-128 or DataMatrix)
Human-readable GTIN
Including production identifiers like lot number, expiry date

Refer to the GS1 UDI Guidelines for compliance details.

Step 7: Register Your GTINs in EUDAMED

Once EUDAMED is fully operational or once your country requires it:

Use your GTINs as Device Identifiers during UDI-DI registration.
Ensure each GTIN matches product information and label data.

Frequently Asked Questions

Q: How much does it cost to get GTINs?

Fees vary by country and company size. Most GS1 organizations charge an annual fee and a one-time registration fee.

Q: Can I reuse GTINs for future products?

No. GTINs are unique and permanent. Reuse is not allowed under EU MDR.

Q: What if I only have one product?

You still need to license a company prefix, but some GS1 offices offer single GTIN licenses for small companies.

Summary Checklist

✅ Register with your national GS1 office

✅ License a GS1 Company Prefix

✅ Generate GTINs for each product configuration

✅ Label products with compliant barcodes and UDI

✅ Register your devices and GTINs in EUDAMED