Highlight sessions from the barcoding success webinar series with key information for medical device suppliers.
This series of short, prerecorded presentations will help you navigate your way through the language of GS1 and medical device regulations to meet the requirements to identify and barcode your products.
Getting started with the foundations
We begin with an introduction to GS1 standards in healthcare providing a high-level overview of GS1 and how the standards are used to meet healthcare regulatory and trading partner requirements.
When coming to this subject for the first time the language can be confusing. The glossary of GS1 and EU MDR UDI terms provides a glossary and brief explanation of acronyms and terms commonly used throughout the other modules.
One of those terms is UDI. What is UDI – unique device identification? This is an important aspect of medical device regulations in several markets and is expanding into more including Great Britain.
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Introducing the GS1 Identification Keys
The EU Medical Device regulations introduced the concept of the Basic UDI-DI (GMN). Find out more about what it is and how it is created.
When using GS1 standards it all starts with a number – the GS1 Company Prefix (GCP). When you join GS1 UK, we licence you a unique Company Prefix. And from this simple start, you can identify all your products and so much more.
There are different length GTINs that can be created from your GS1 Company Prefix. Assigning the correct GTIN from this GCP to use for your product and packaging levels is vital.
Getting the barcode data right
When it comes to choosing the right barcode for regulated healthcare products, you need to consider the product packaging hierarchy and whether the product is for professional and or consumer healthcare.
There is a very important and often overlooked aspect to consider to capturing the GTIN-13 in a GS1-128 and GS1 DataMatrix. Avoid making this common mistake when creating your barcodes.
A common question is how to encode Production Identifiers such as LOT/Expiry date etc. into GS1 barcodes. This is the UDI-PI element of the UDI.
Barcoding best practice
Barcode size plays an important role in making sure the barcode is of sufficient quality to scan. The minimum, target and maximum size of the barcodes have been determined through working with industry. Different sizes are required for different barcode types within different scanning environments.
When you’re ready to start creating the GS1 barcode to capture the UDI, you’ll need to use a third party software application.
To meet the regulations, lots of data is captured in the barcodes but how do you present the data in the barcode on the label in human readable format?
You've come this far and now need to know how to ensure a barcode will scan to ensure it can be used at the point of care or use.
GTIN allocation
Looking to the future we need to consider what impact product changes will have on the GTIN allocation.
Many healthcare suppliers are not aware of, or fully understand, which changes to their products would require a new GTIN.
The GTIN Allocation Rules have been designed to help industry make consistent decisions about when to change GTINs.
