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Survey reveals main labeling challenges facing medical device manufacturers

The survey, carried out by PRISYM ID, a leading provider of turn-key labeling solutions for the medical device and life sciences industries, identified label defect control as one of the top issues currently facing almost 40% of medical device and pharmaceutical companies.

In addition, for 40% of medical device respondents, UDI compliance posed a significant challenge. With the new UDI regulations for Class III devices requiring compliance from 24th September 2014, and the Class II requirements to follow in 2015 and 2016, this challenge is only set to escalate. For 58% language management within the labeling process presented its own challenges. The conclusion is that a substantial percentage of medical device manufacturers are facing consequential issues of time and money loss, unnecessary waste, reputation risk and potential patient safety concerns.

Warren Ward-Stacey, PRISYM ID commented: “The results of these findings are not particularly surprising, however what is a concern is that 40% of those surveyed still do not have a solution in place to control these issues. A streamlined end-to-end label lifecycle management solution that enables companies to effectively manage data and ensure a single version of the truth is vital to help reduce unnecessary product recall, increase profit and improve supply chain efficiency.

“It is clear that a complete label lifecycle management solution that meets country specific requirements, supports expansion and communicates coherently, is crucial for ensuring regulatory compliance and efficiency gains”.

PRISYM ID’s revolutionary solution PRISYM 360 allows for integration with UDI submissions providers to deliver a streamlined end-to-end submission process that supports compliance and helps ensure label integrity. In a direct response to client feedback, PRISYM ID developed PRISYM 360 to address the key issues for medical device and pharmaceutical companies. This efficient solution removes the challenges of UDI compliance, language management and label defect control and simultaneously reduces unnecessary product recalls, increases supply chain efficiency and ultimately improves patient safety.


This article was published on December 1st, 2014