Check It Out: Free Video Available
While you're gathering your motivation to read yet another article on regulation, let me jump in briefly! We've actually recorded a video on this topic in the meantime. In our videos, we try to be to-the-point and super concrete, so you'll learn exactly what you need to write your own documentation. Check it own below and take a look for yourself!
And if you liked this video, take a look at our UDI video course in which you can watch us literally purchasing UDIs at GS1 and IFA. We explain what we're doing and how you can get your UDIs, too! Much more efficient and cheaper than paying consultants (like us) to do it for you :)
But now, let's move on to the actual article.
What is GS1? And how do we get GS1 UDIs?
GS1 provides “one global system” for product identification. It’s a company that sells numbers to businesses. Those numbers help identify the products throughout the entire supply chain. Medical device manufacturers use the GS1 system to create their UDIs.
GS1 is a global non-profit organization that develops and maintains standards for various industries to enable efficient business processes and seamless communication between trading partners. In normal words: it sells numbers to you and makes sure they are unique. GS1 operates 116 local subsidiaries and serves over 2 million user companies. Its headquarter is in Brussels.
The unique identification numbers, such as barcodes and product numbers help in identifying products, services, assets, and locations in supply chains and other business operations. GS1 standards are used in a wide range of industries, including retail, healthcare, food and beverage, logistics, and more.
Almost every barcode that you come across has been issued by GS1. Product codes come in the form of an EAN (European Article Number), a standardized barcode symbology used to uniquely identify products for retail and distribution purposes. EANs are a subset of the broader GTIN (Global Trade Item Number) system developed by GS1. The primary function of an EAN is to provide a scannable code that represents product information and allows for quick and accurate data entry in retail and supply chain systems.
In the context of healthcare, GS1 standards play a crucial role in ensuring patient safety and regulatory compliance. In the European Union, the Medical Device Regulation (MDR) requires medical device manufacturers to assign Unique Device Identifiers (UDIs) to their products. GS1 standards are the most common way to achieve this. It’s not the only option though.