GS1 welcomes the adoption of the final EU Regulations on medical devices and on in-vitro diagnostics. GS1 global standards will be used by manufacturers to implement the new EU system of Unique Device Identification (UDI), which aims to support patient safety and supply chain security.
The UDI system intends to provide a globally harmonised framework for identification of medical devices to enhance quality of care, patient safety and business processes.
This is a historical milestone that not only aligns regulation in the EU with the US, where UDI has been instrumental for the role of GS1 standards in the medical devices and healthcare, but also paves the way for other countries to adopt these requirements.
Miguel Lopera, GS1's CEO commented that ''UDI systems based on GS1 standards will benefit patients, the healthcare system, and the medical device industry. GS1 standards assist healthcare organisations around the world to quickly identify medical devices in the case of recall. They improve the accuracy and specificity of adverse event reporting and provide a foundation for a global, secure distribution chain''
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