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.