Combatting Medical Device Counterfeits with 2D Codes – Taking Serialisation Beyond EU MDR Compliance

The counterfeiting of health products is a serious and growing concern, with governments and regulators taking increasing action to improve traceability and protect patients and consumers from harm. Today, all prescription pharmaceuticals sold in the EU and the US, and the top 300 pharmaceutical brands in India, are subject to complete end-to-end traceability from the point of manufacture to the point of dispense. However, compliance for medical devices, introduced in the upcoming EU Medical Device Regulation (EU MDR), is not as strict.

The medical device sector should take inspiration from the deployment of serialisation via 2D codes within pharmaceuticals. Taking a step beyond current legislative requirements, can reduce the risk of counterfeit products further, and bring additional benefits to both end-users and manufacturers, as Bart Vansteenkiste, Global Life Sciences Sector Manager, Domino Printing Sciences, explores.

The state of counterfeiting within the medical device sector

Medical devices are an extremely broad category, covering everything from bandages and personal protective equipment (PPE) to pacemakers and ventilators. The consequences of using counterfeit medical devices can also vary greatly, from sub-optimal performance or improper function to causing severe harm to end users.

Counterfeiting is a serious problem in the global medical device industry. Vulnerabilities in global supply chains were brought to the fore at the very start of the COVID-19 pandemic, when counterfeit test kits, face masks, and PPE appeared seemingly overnight. Many companies that had not previously manufactured medical devices entered the marketplace with disposable masks and PPE to satisfy a dramatic increase in demand - and not all companies manufactured products to the standards required for use in medical settings. During the COVID-19 pandemic, authorities in 90 countries confiscated more than $14 million worth of counterfeit antiviral medications, face masks, and over-the-counter test kits through a global operation called Pangea XIII. In total, authorities around the globe confiscated 9 million units of illicit and counterfeit products.

While we have come a long way since the start of the pandemic, this is still a significant issue. Interpol's most recent operation, which ran from 3 to 10 October 2023, led to the seizure of approximately 11,000 counterfeit COVID-19 test kits in Australia alone.

The global rise in ecommerce has played a significant role in promoting counterfeit sales of medical devices, with online marketplaces and ecommerce platforms offering a convenient place for consumers to shop and compare prices to find the best deals - or access products not available in their local markets - while providing a breeding ground for counterfeit products. Findings from the US Government Accountability Office have suggested that as many as two of every five consumer products available online through third-party retailers could be counterfeit.

The sale of counterfeit medical devices is, first and foremost, a safety concern but can also have significant economic repercussions. According to the World Health Organization, around 2 billion people worldwide lack access to necessary medical devices and pharmaceuticals, which has driven the demand for lower-cost products and increased the supply of counterfeit products. This is especially true for those in low- and middle-income countries, which spend an estimated $30.5 billion on substandard and counterfeit medicines, raising disease prevalence, wasting resources, and increasing out-of-pocket spending.

Medical device regulation today

The upcoming EU Medical Device Regulation (EU MDR) stipulates that manufacturers of medical devices for sale within the EU must adhere to guidelines to ensure their products are safe to use. The regulations cover all medical devices sold in the EU, irrespective of the manufacturer's location.

Whilst strict, the EU MDR currently contains only minimal requirements for individual device identification. Under the regulations, all medical devices must be assigned a unique device identification (UDI) code and have their UDI recorded, indexed, and registered in EUDAMED, the Central European Database for Medical Devices.

Publication and full functionality of EUDAMED are expected to be in place by the end of 2024, and full use will be mandatory for all medical 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 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

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.

Public link

Please use the above public link if you want to share this noodl on another website.