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Unique Device Identification (UDI) for medical devices using the GS1 system
The USA’s FDA (Food and Drug Administration) and the European Commission have introduced new regulations over the last few years to ensure that all medical devices are appropriately identified and barcoded.
This means that all medical devices must be identified with a Global Trade Item Number (GTIN) or its equivalent using the HIBCC (Health Industry Business Communications Council) system which is a UDI-DI (Unique Device Identification – Device Identifier). Some medical devices must be further identified with a batch number, serial number, expiry date, or manufacturing date, depending on the type of medical device it is.
All devices will be recorded in centralised databases. For the USA this is GUDID (Global Unique Device Identification Database) , and for the EU this is EUDAMED (European Databank on Medical Devices). The UK does not require UDI-DI as the UK does not have to meet EU requirements.
Basic UDI-DI, UDI-DI and UDI-PI
First of all, each device must be assigned a unique Basic UDI-DI (Basic Unique Device Identification – Device Identifier), a unique reference for the type of device it is, and this will be used in database records but never shown in a barcode on the item. The GS1 system has developed the GS1 Global Model Number for this purpose, and this is a unique key that begins with a GS1 company prefix number and which is alphanumeric and variable length of up to 25 characters.
Each device is then identified with a UDI-DI (device identifier) which for GS1 users is a GTIN.
Those devices in the higher-risk categories must also be identified with extra data such as batch number, serial number, expiry date, or manufacturing date, dependent upon the type of item it is.
This extra data is known as UDI-PI (product information) and this will be defined by GS1 Application Identifiers when encoded in a barcode.
So for example, a certain device may be identified with a label encoding the following data:
GS1-128
GS1 DataMatrix
The UDI-DI is 9521234500018, a GTIN-13. It is shown above in the 14-digit field that must follow the AI 01.
The UDI-PI is batch AB12345, serial number 100200312, and expiry date 28 February 2023.
The Basic UDI-DI will be a GS1 Global Model Number, and an example is 95212345Abcd12SB.
For this example, the GMN is formed from the GS1 company prefix 95212345, the model reference Abcd12, and the double check characters S and B. This is never encoded in a barcode and used only within database records.
Implementation deadlines
The EU deadlines for the marking of medical devices are as follows:
26 May 2021 – Implantable and Class III devices
26 May 2023 – Class IIa and IIb devices
26 May 2025 – Class I devices
Reusable devices requiring direct marking are required to be marked with UDIs two years after the date applicable for its respective class of devices.
More information about the different classes and what they require is set out below.
Classifying the medical devices
All medical devices must be classified into one of four categories that move from low-risk to high-risk items, and these classes are Class I, Class IIa, Class IIb, and Class III. Examples of these classifications are given below.
Class I – lowest risk: syringes without needles, medicine spoons, spectacle frames, standard adhesive bandages, examination lights.
Class IIa - short-term corrective contact lenses, suture needles, standard hearing aids, TENS devices.
Class IIb – apnoea monitors, ventilators, surgical lasers, diagnostic X-ray sources.
Class III – highest risk: pacemakers, total hip joint replacement system, breast implants, contraceptive IUDs, devices containing medicinal substances.
For Class I items, the UDI-DI is the GTIN.
For Class III items, the UDI-DI is the GTIN but UDI-PI must also be provided.
Class IIa and Class IIb requirements will depend upon the type of device itself.
The USA’s FDA has classified over 1,700 different types of medical device, and approximately half are in Class I. Class II accounts for about 40% of these devices, and Class III for about 10%.
Neither GS1 nor Axicon can determine into which category a product falls as this must be the decision of the medical device manufacturer following the guidance provided by the FDA and the EU.
All medical devices are regulated and the classification for UDI purposes is only a minor part of the procedures that will need to be followed before a device can enter the market.
Which barcodes can be used?
Some medical devices will only need to be identified with their GS1 Global Model Number and a GTIN. The GMN will be recorded in the relevant database, and the GTIN will be barcoded on the item. As with other trade items, different levels of packaging will require different GTINs, and variants of the base medical device (with the same Global Model Number) will also require different GTINs at all levels of packaging.
Some medical devices will simply need to be marked with a UPC-A or EAN-13 symbol.
Those that must be identified with PI (production identifier) as well as the GTIN, will be identified with either GS1 DataMatrix, GS1-128 or GS1 DataBar family symbols.
Different levels of packaging of medical devices will mean that some could be marked with ITF-14 symbols as well as GS1-128, GS1 DataMatrix or GS1 DataBar family symbols.
The only symbol that should not be used is GS1 QR Code as this is not allowed for healthcare products.
How can the Axicon camera verifier plugins help?
There are four plugins that are relevant. The first three are GS1 Healthcare Retail, GS1 Pharmacy Distribution, and GS1 Healthcare (Bedside). These will check that the barcode is allowed for this application, that it is the correct size, and that the print quality meets the minimum requirements. hey cannot check that you have correctly identified the item with, say, a GTIN plus batch number plus expiry date because the extra data requirement will depend upon the type of medical device.
Most single medical devices will be expected to meet the criteria of the GS1 Healthcare Retail plugin (as set out in Symbol Specification Table 10 of the GS1 General Specifications). Outercases of medical devices should meet the criteria of the GS1 Pharmacy Distribution plugin (set out in SST 8 of the GS1 General Specifications).
Some very small medical devices may need to meet the criteria of the GS1 Healthcare (Bedside) plugin. The fourth plugin, Pharmapack, will check that a GS1 DataMatrix symbol is present, and that it encodes GTIN and batch number and expiry date, and this will be relevant for some medical devices.
Where to find more information about UDI
https://www.fda.gov/medical-devices/unique-device-identification-system-udi-system/udi-basics
https://eu-udi.zendesk.com/hc/en-150
https://www.gs1.org/industries/healthcare/udi
https://www.hibcc.org/udi-labeling-standards
https://www.gs1.org/standards/barcodes-epcrfid-id-keys/gs1-general-specifications
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