New EU Unique Device Identification regulations align with US and recognise the vital role of GS1 standards
EU regulations demonstrate how GS1 standards deliver patient safety and supply chain security
London, 7 April 2017… GS1 UK, part of the global not-for-profit standards organisation, welcomes 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, 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,” added Glen. “This is a huge step forward for patient safety and will support the great improvements in efficiency that the Scan4Safety programme is already delivering throughout the NHS.”
These new regulations mark a significant achievement, and are the culmination of over four years of intensive work by the European Parliament and the European Commission with the active support of the healthcare community.
Bruno Aceto, GS1 in Europe’s Chairman, said “The EU has made safety and integrity of the global healthcare supply chain a strategic priority by adopting legislation for UDI for medical devices. The successful implementation of UDI by all healthcare stakeholders, from manufacturers to healthcare providers, will depend on several factors, including a globally standardised and harmonised system. The 47 national organisations composing GS1 in Europe, the European platform of GS1, are available to help companies implement the GS1 standards to answer regulatory requirements.”
GS1 UK has been working with healthcare manufacturers to help them create and maintain UDI numbers by following the EU regulations. According to the regulations, a UDI number must be applied to the medical device label, its packaging and, in some cases, the device itself. Required product data must be submitted to Eudamed, the central European database. GS1’s global identification and coding systems are compliant with relevant international ISO standards.
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).
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About GS1 UK
For further information or requests for interviews, please contact Tim Haidar: 020 7092 3584 / Tim.Haidar@gs1uk.org.
GS1 UK is a community of over 31,000 members working in healthcare, retail, foodservice and more. GS1 UK is one of 112 independent, not-for-profit GS1 organisations operating across 150 countries worldwide. GS1 UK helps everyone involved in making, moving and trading goods, automate and standardise their supply chain processes using the common language of GS1 global standards. In healthcare, we work with providers and suppliers to improve patient safety, enhance clinical effectiveness and drive operational efficiencies. GS1 standards are helping the NHS save thousands of lives and millions of pounds.