Copyright ©GS1 Saudi Arabia - 2023 All rights reserved.
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.
