The United States Food and Drug Administration (FDA), the European Commission and other regulators have made patient safety a strategic priority by developing legislation for Unique

Device Identification (UDI). UDI is expected to improve patient safety and healthcare business processes. A single, global system of standards is fundamental to enable an efficient and

effective implementation of UDI by all healthcare stakeholders worldwide.

What is UDI?

A Unique Device Identification (UDI) system is intended to provide single, globally harmonized positive identification of medical devices through distribution and use, requiring the label of devices to bear a globally unique device identifier (to be conveyed by using Automatic Identification and Data Capture and, if applicable, its Human Readable Interpretation) based upon standard, with the UDI-DI (Device Identifier) of that unique identifier being also linked to a jurisdiction-specific public UDI database (source: International Medical Device Regulators Forum (IMDRF): http://www.imdrf.org/)

Unique Device Identification (UDI) improves patient safety and healthcare business processes and will require significant implementation investments by manufacturers, providers and other healthcare organisations. A single, global system of standards is fundamental to enable an efficient and effective implementation of UDI by all healthcare stakeholders worldwide. The GS1 System of standards provides a global framework to identify, capture and share healthcare product information, thereby enabling a worldwide implementation of UDI.

GS1 standards for UDI

The GS1 system of standards supports all stakeholders to efficiently and effectively meet UDI requirements by enabling interoperability and compatibility within an organisation, between organisations and across borders. A single standard can ultimately accelerate implementation and increase compliance to the UDI

How to apply a UDI code?

Once generated, each UDI code must be applied in both human and machine readable form. The UDI code should be on each applicable packaging level, from the unit of use to the highest package level. Each designated packaging level that is a trade item must have its own DI (GTIN). Logistics units3 are exempt. “Direct marking” is required for certain devices, which are intended to be reused or reprocessed. The labeler/manufacturer must determine whether their products fall under Direct Marking criteria or whether their products meet an existing exception. Specifications vary by the issuing agency. It is important to understand and to follow the GS1 GTIN Management Rules to ensure the accurate allocation and application of the UDI code.

When to get your UDI?

The UDI (Unique Device Identification) is mandatory for medical devices according to the MDR as of now. However, there are different grace periods depending on the classification:

MD Class III: May 26, 2021

MD Class II: May 26, 2023

MD Class I: May 26, 2025

IVD Class D: May 26, 2023

IVD Class B & C: May 26, 2025

IVD Class A: May 26, 2027

For simplicity, we’ll just look at GS1 and how their standards translate to the UDI system.

The companies do not issue UDIs per se, but they do issue their own standardized numbers and codes, which then translate to the UDI requirements. So don’t despair when searching for the button where to buy the UDI.

By the way: It makes sense to get your UDI from GS1, especially if you’re planning to sell your device in many markets. GS1 standards are acknowledged by most of the countries (incl. USA, EU, India, China, Japan) whereas for example IFA standards are only accepted in the EU. For HIBCC and ICCBBA it would make sense to check whether those standards are accepted in your target markets.

Which UDI to get?

It would be too simple if you could just order one number for your device, wouldn’t it? So here you go:

At first, you need a Basic UDI-DI.
Then, you need the UDI-DI.
And then you need a UDI-PI, but you can come up with that by yourself.

You only need one Basic UDI-DI per device, but the UDI-DI changes with every significant update, so it makes sense to buy several of them.

The confusion is virtually pre-programmed, as the regulators were once again not particularly creative when it came to inventing the terminology. Just try to avoid mixing up Basic UDI-DI and UDI-DI.

How to get my UDI from GS1?

at first, you need to subscribe with GS1 Saudi Arabia. Then, within 2 working days, you’ll get access on your GCP (GS1 Company Prefix) and your GLN (Global Location Number). You need them later to generate your UDIs using the GS1 UDI System.

BASIC UDI-DI

From GS1, you can use the GMN <(Global Model Number) as Basic UDI-DI.

Generating the GMN (Basic UDI-DI):

Go to the GS1 GMN Generator.

Take your GCP (GS1 Company Prefix), which is the “Basic number” in your GS1 Dashboard.

Provide an arbitrary name for your product class as “Internal number, or model reference”. Watch out: It’s case-sensitive.

Hit “Calculate”.

The calculation that has been done is reflected in the “check pair”, which is the red “X8” in our example. You can enter the X8 in the text box above and “validate” it. I’m not sure why you’d ever want to do that.

UDI-DI

A new UDI-DI is required whenever there is a change that could lead to misidentification of the device and/or ambiguity in its traceability; in particular, any change of one of the following UDI database data elements shall require a new UDI-DI:

(a) name or trade name,

(b) device version or model,

(c) labelled as single use,

(d) packaged sterile,

(e) need for sterilization before use,

(f) quantity of devices provided in a package,

(g) critical warnings or contra-indications: e.g. containing latex or DEHP.

A new UDI-DI shall be required whenever there is a modification that changes:

(a) the original performance;

(b) the safety or the intended use of the software;

(c) interpretation of data.

Such modifications include new or modified algorithms, database structures, operating platform, architecture or new user interfaces or new channels for interoperability.

The UDI-DI therefore changes for significant modifications to the device.

In GS1 this number is the GTIN (Global Trade Item Number). It should appear in EUDAMED and on the product label.

The GTIN is composed of the GLN (Global Location Number), a numbering of the product variant and a check digit, which is automatically calculated. You can set a GLN in the GLN System.