Medical Device

As merger & acquisition activity continues to be a strategic play for Medtech companies seeking to enrich their product portfolio and deepen expertise there is an increasing need to achieve rapid harmonisation across both regulatory and marketing driven labelling content. Increasing regulation and enforcement is also driving these organisations to seek solutions to better manage product & package labelling and to reduce compliance risks. The trends have a direct impact on artwork and labelling with 75% to 90% of artwork activity being driven by changes.

For medical device manufacturers, the definition of what constitutes a ‘label’ is very broad, including Instructions for Use (IFUs), technical data sheets and other documents. The requirements for international product delivery are also particularly onerous: there are more than 10 unique medical device codification systems in the EU alone. Meanwhile the array of product identification standards currently in use – including GS1, HIBCC, EAN, and UPC– is at odds with the drive to harmonise processes along the supply chain, which for medical device manufacturers can include contract manufacturers, private label and re-label partners, distribution points and healthcare providers.

Possibly more than ever before, changes to legislation will impact medical device manufacturers as new rules covering device identification have an increased effect over the next two years.

The FDA’s roll-out of Universal Device Identification (UDI) system for all Class I devices from September 24, 2018 requiring a step change to accommodate the tens and possibly hundreds of thousands of devices affected per manufacturer. A similar approach is being adopted across the EU with the new Medical Device Regulations (MDR) requiring manufacturers to assign a unique device identification to increase levels of patient safety and address the need for traceability. Device manufacturers have until late 2019/early 2020 to demonstrate compliance across their product portfolio.

In addition, 2016 saw the FDA issue a final rule to allow for the use of standalone symbols on medical device and in vitro diagnostic (IVD) labels in an effort to align with international standards. The move to also allow medical device manufacturers to publish Instructions for Use (IFU) leaflets in electronic format rather than being paper based is adding momentum towards greater adoption of e-Labelling. This will make it easier for manufacturers to keep content up to date and make prompt changes driven by changes to requirements and/or product functionality. Taking advantage of this option will require a more structured approach to content management.

Taking into account global reach, the complexity of language, local market variations and the volume of product labels managed, a technology driven approach is the only realistic option for managing such a diverse and dynamic environment. Kallik’s software alleviates these complexities by providing central control and a clear line of sight across all packaging and labelling activities, enabling artwork and content to be changed reliably, efficiently and definitively at the source. This also leads to more accurate and timely compliance reporting. The increased efficiency and reduced compliance risks achieved by taking this approach will help deliver competitive advantage within existing territories and when entering new growth markets.

Kallik’s cloud-based solution also makes it easy to drive out quality across extended supply chains de-risking the engagement of engaging with 3rd party manufacturers and distributors, including Contract Manufacturing Organisations (CMOs) and Contract Development and Manufacturing Organisations. In doing so, we help medical device manufacturers become sufficiently agile to ensure strategic alignment with both existing and emerging legislation and avoid any potential lock-in through choosing less flexible solutions.

Contact the team today to find out more or visit our UDI Resource centre.