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BARCODING, LABELLING & PACKAGING
supply chain – from improved production line efficiency and access to supply chain data to enhanced operational performance. Moreover, serialisation has also facilitated
new commercial opportunities in other industries, as it has proven to be the foundation for digital marketing capabilities, including personalised consumer engagement and improved brand positioning. Via serialisation, manufacturers can gain key insights into a product’s lifespan and distribution trends to facilitate strategic planning. Such data could, regulations permitting, present an opportunity for sales teams to engage with pharmacy chains and retailers to improve sales performance or engage in consumer-focused marketing. Applying product serialisation can also help
protect patient and consumer health and safety and make product information more accessible, dynamic, and consumer-friendly. By embedding serialised data within scannable 2D codes, medical device companies can help make product-specific information, such as user guides, easier for users to access while also ensuring that the guidance is up-to-date and accurate – and in formats (e.g. non-paper) that are more accessible to them. In addition, unlike when EU FMD and US DSCSA were introduced, today the cost of serialisation through 2D codes has significantly reduced as knowledge has grown, making it much more efficient and cheaper to install across a range of markets. Today, serialised technology is being used in many low-cost sectors, including fresh fruit and vegetables and even postage stamps.
CONCLUSION
device manufacturers with staggered deadlines from 2026 to 2028.
THE UDI CONTAINS: Device identifier – a unique text code for each specific model of a particular device. The information is static, meaning it is the same for all instances of the product model. Production identifier – a variable text code
comprising one or more variable characteristics, such as the date of manufacture, expiration date, lot number, or serial number. Initially, serialisation and identification of
products down to the individual item level will only be a requirement for active implantable devices, such as pacemakers, ventilators, and internal glucose monitors. However, there are a vast range of benefits that would apply to broader medical device manufacturers who choose to equip their production lines with technology to enable both UDI compliance and serialisation. Not only will such a forward-thinking strategy
help combat the rise and risk of counterfeit medical devices, it will also help manufacturers future-proof their lines should the requirement for serialisation be extended to include more product groups. In addition, those who implement serialisation can also stand to benefit
substantially from tracking a product’s progression from creation to the end user, gaining supply chain data that can be used to enhance operational and commercial performance – as evidenced by the deployment of serialisation within the pharmaceutical sector.
THE HIDDEN BENEFITS OF SERIALISED TRACK AND TRACE In recent years, many global regions have mandated serialisation requirements that enable all pharmaceutical products to be tracked and traced throughout their journey in the supply chain, from manufacturer to end user. Current legislations include the EU Falsified Medicines Directive (EU FMD), and the US DSCSA (Drug Supply Chain Security Act). A similar regulation is currently being rolled out by the Ministry of Health in India, with an initial phase covering the top 300 pharmaceutical brands having been launched in 2023. The benefits of serialised track and trace in
terms of boosting patient safety and the security of legitimate medicines, are well documented. What should also be considered is the wealth of data that serialisation has presented for pharmaceutical manufacturers and how this has been used to build efficiencies in the broader
The addition of serialisation via 2D codes for medical devices is only a small step beyond what is already required under EU MDR compliance – but it represents a giant step that can not only help to reduce the risk of counterfeit products further but bring a myriad of benefits to both end-users and manufacturers. The adoption of protocols for medical devices based on well-known and trusted serialisation procedures is an essential step towards a secure system that ensures transparency and accountability in the medical device sector. In addition, advanced traceability metrics could allow further supply chain analytics using artificial intelligence and machine learning tools. With a thorough data set enabled via product serialisation, such tools could be applied to instantaneously examine vast quantities of data to identify trends and inconsistencies in the supply chain. Globally, an increasing number of
manufacturers beyond the pharmaceutical sector are realising the opportunities of 2D code-enabled serialisation. For those in the medical device sector who are not yet exploring the possibilities, the time to act is now.
Domino Printing Sciences
www.domino-printing.com
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