GS1 UK has welcomed the adoption of the final EU regulations on medical devices and 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 EU Medical Device Regulation (MDR) and In-vitro Diagnostic Regulation (IVDR), adopted this week, define the requirements for the EU UDI system. In the global supply chain for medical devices this is another step towards a single identification standard that is capable of tracing devices everywhere they go.
Glen Hodgson, head of healthcare at GS1 UK, said “Using GS1 standards for UDI benefits patients, the healthcare system and the medical device industry. We’re working with healthcare organisations to help them identify medical devices, which will help make recalls quicker and more efficient – particularly compared to the often incomplete paper-based systems often used today.
“GS1 standards for UDI provide the foundation for a global, secure healthcare supply chain by recording accurate data for adverse events and documenting the use of medical devices in electronic health records and clinical information systems. This is a huge step forward for patient safety and in the UK it will support the great improvements in efficiency that the Scan4Safety programme is already delivering throughout the NHS.”
The GS1 standard for item identification (the GTIN) is used across the global healthcare industry as a unique identifier for medical and surgical products at every level of packaging. Since 2013, GS1 has been accredited as an issuing agency for UDI by the US Food and Drug Administration (FDA).
