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March 30, 2021


Addressing Medical Device Labeling & Compliance Challenges

Susan Gosnell

The medical device industry is poised for growth in the coming years. This presents opportunities for many, but also immense challenges and greater strain on the supply chain. And considering that the medical device industry is highly regulated, these companies also have to pay special attention to varying requirements across borders, lengthy approval processes and non-compliance penalties – all of which can further complicate the supply chain and lead to costly setbacks or shipping delays.

Overcoming these challenges can be crucial to success. But let’s focus on a very important component of the supply chain, labeling. Dated labeling processes, like locally managing disparate label data sources and printers across facilities or manually hard coding thousands of label templates, just aren’t cutting it.

Simply put, taking a modern, digital approach to labeling can be key for any medical device manufacturer to stay compliant, gain a competitive edge and improve supply chain operations on a global scale.

The Challenge of Compliance Across Borders

Medical device manufacturers who operate internationally need to align their labeling with varying standards, like the US Food and Drug Administration’s (FDA) rules and the EU Medical Device Regulation (MDR).

In many cases, small differences between regulations can be highly consequential. For instance, a medical manufacturer shipping to the US that has already met FDA compliance may be 90% of the way to complying with MDR as well. However, a multitude of nuanced differences can require varying designs that could be costly and can quickly halt a supply chain in its tracks.  

Streamlining Labeling with Dynamic Templates and Integration

Whether shipping domestically or overseas, streamlining label management can provide a plethora of benefits. For instance, switching from hard-coded templates to dynamic ones will ease the burden on IT caused by cumbersome design changes. Furthermore, teams can digitize entire quality assurance and control processes, so manufacturers can implement better workflows for label changes and approvals, without manual processes like printed proofs. 

Going a step further, manufacturers can even automate label change and approval processes on a large scale across multiple locations, which eliminates the need to individually design and approve hundreds or thousands of labels for each stock keeping unit (SKU).

Integration is vital because PLM, MES and ERP systems are the truth source for crucial info like the device identifier (DI) and product identifier (PI) data needed to satisfy multiple regulations, such as portions of both the US FDA and EU MDR requirements.

Moving to the Cloud: A Key to Easing Label Design and Validation

Cloud-based label management systems are becoming indispensable for many medical device manufacturers, especially for those who don’t want, or can’t afford, to invest in the fixed costs of an on-premise label management system.

By using a cloud-based labeling system designed for medical device labeling, organizations can quickly integrate labeling with other systems and gain access to crucial tools like validation documentation and readily compliant label templates that are updated on a regular basis to ensure compliance. 

From a workflow standpoint, cloud-based systems can also make it easier to manage designs and compliance with capabilities like role-based access to documents, version control, configurable approval processes and an extended print history with a detailed record of what was printed and when.

Future-proofing Labeling

The ability to efficiently ensure compliance, no matter where devices are shipped or what regulations change, is becoming increasingly important. This is why technologies like digital label management or cloud-based solutions that make implementing label management easier than ever are quickly becoming an essential component to any medical device manufacturer’s arsenal. 

To learn more about how your company can benefit from a cloud labeling solution built for life sciences companies, visit www.loftware.com/label-cloud-compliance.

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