UDI-DI, Basic UDI-DI, GTIN, and GMN: What’s the Difference?
The European Union’s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) require manufacturers to assign Unique Device Identifiers (UDI) to their products. These identifiers include the UDI-DI and Basic UDI-DI, both of which must be registered in EUDAMED. Understanding how these terms relate to the GS1 system, specifically GTIN and GMN, is key to ensuring compliance.
UDI-DI vs. Basic UDI-DI: Definitions from GS1
According to the European Commission’s guidance on UDI and device data for EUDAMED, manufacturers need to provide both UDI-DI and Basic UDI-DI. GS1, a leading standards organization for identification, provides the following definitions:
- UDI-DI = GS1 GTIN (Global Trade Item Number)
- Basic UDI-DI = GS1 GMN (Global Model Number)
It’s important to note that GTIN is not the same as GMN. These identifiers serve different purposes, and manufacturers need to understand their specific uses in the GS1 system.
What is a GTIN?
A >Global Trade Item Number (GTIN) is a unique identifier assigned to each specific trade item (e.g., a product or package) for use in commerce. It’s used to uniquely identify sold logistics units. For example, if your company has a Global Company Prefix of 753030353, your GTIN numbers would look like this:
753030353XXXC
- XXX: A series of digits chosen by the manufacturer.
- C: A checksum digit calculated using GS1’s online tool.
Each GTIN must be unique to a specific item. Manufacturers have the freedom to choose the numeric values of the GTIN within their allocated range, ensuring there is no overlap among their products.
What is a GMN?
The Global Model Number (GMN) is used for the Basic UDI-DI and represents a grouping of devices under the same model. Unlike GTIN, which is specific to each trade item, the GMN identifies the broader family of devices and serves as a key grouping mechanism.
For instance, if your Global Company Prefix is 753030353 and you choose the model reference AAAAA for a medical device, the GMN would be structured as:
753030353AAAAAW8
- AAAAA: Your internal model reference.
- W8: The check character pair calculated by GS1’s tool.
Key Differences Between GTIN and GMN
| Feature |
GTIN (UDI-DI) |
GMN (Basic UDI-DI) |
| Purpose |
Identifies specific trade items or logistic units. |
Groups devices under the same model or family. |
| Scope |
Unique to each product or package. |
Represents a device family, not individual products. |
| Format |
Includes digits from the Global Company Prefix and a checksum. |
Includes the Global Company Prefix, model reference, and check characters. |
How to Generate GTIN and GMN
To create GTIN and GMN identifiers, follow these steps:
- Assigning GTIN - use your Global Company Prefix, select a unique number for the product, and calculate the checksum using GS1’s tool.
- Creating GMN - use your Global Company Prefix, assign a model reference (max 23 characters), and calculate the check character pair with GS1’s tool.
Conclusion
The relationships between UDI-DI, Basic UDI-DI, GTIN, and GMN are important to regulatory compliance for medical devices under the European MDR and IVDR. Here's a brief breakdown:
- UDI-DI (Unique Device Identifier – Device Identifier) corresponds to the GTIN (Global Trade Item Number) in the GS1 system. It uniquely identifies specific trade items or product variations, such as different package sizes or configurations.
- Basic UDI-DI aligns with the GMN (Global Model Number) in GS1 terminology. It serves as a grouping mechanism for a family of devices sharing the same model or intended purpose.
Key Distinctions
- GTIN (UDI-DI): Unique to individual products or logistic units.
- GMN (Basic UDI-DI): Represents a device family, focusing on broader product groupings.
While GTIN and GMN are integral to the GS1 system, their correct application ensures compliance with EU regulatory requirements, facilitates product traceability, and supports data submissions to EUDAMED.
