This paper clarifies the GS1 Healthcare community guidance on the use of GS1 DataMatrix within the healthcare sector. With more and more regulations being developed across the world to enable traceability, pharmacovigilance and post market surveillance, as well as digital health advancement, there is an increased need for product identification data to be captured through scanning barcodes placed on medical products (pharmaceutical and medical devices) and their packaging. The recommendation of the GS1 Healthcare community is for the use of GS1 DataMatrix for the identification of medical products, when the scanning environment, data and regulatory requirements make the usage of a 2D instead of a linear barcode necessary.

For many clinical and non-clinical processes in healthcare the automatic identification of a product is critically important – from an efficient and secure supply chain to improved patient safety. Barcode scanning enables the automatic reading and capturing of product identification data. When choosing the data carrier for automated identification of a medical product, it is important to use the one that has been previously agreed upon by the stakeholders in order not to add cost and/or complexity. Global healthcare stakeholders have implemented the GS1 DataMatrix for many years as the 2D barcode to fulfil medicines traceability regulations in Argentina, Australia, Brazil, Egypt, Ethiopia, Europe, India, Russia, Saudi Arabia, Turkey, USA and many others – in total in more than 75 countries around the world. Equally, many donor organisations are requiring the GS1 DataMatrix on pharmaceutical products they purchase.

The GS1 DataMatrix is also commonly used to meet Unique Device Identification (UDI) requirements in many countries across the globe. There are many reasons for the choice of the GS1 DataMatrix, the most important are:

• Captures the largest amount of identification data in the smallest amount of space on packaging
• Can be printed directly on the products
• Has sophisticated error detection and correction algorithms, allowing the GS1 DataMatrix barcode to be scanned even if damaged, torn or printed poorly