Medical Device Labeling Market Continues Exponential Growth

by Laura Johnson, on July 9, 2018

Medical device labeling requirements around the world are intensifying.
Medical device labeling requirements around the world are intensifying.

As regulations continue to go into effect around the world, compliant and up-to-date medical device labeling has become an essential element of the industry. But meeting regulatory demands doesn't have to be the only priority. Organizations can also take the opportunity to enhance their approaches to labeling, decreasing manual processes and boosting efficiency and accuracy.

When organizations adopt new comprehensive labeling systems to stay on top of regulations, such as the Food and Drug Administration's (FDA) Unique Device Identification (UDI), they can leverage this requirement to ensure their products are optimized for traceability while saving time and reducing costs. With Europe following the U.S.'s lead in updating labeling regulations, the need for action has gone global.

Interest in Labeling Spikes

The present era of escalating regulations and improving technology has increased the focus on labeling. According to Transparency Market Research's latest survey, the dual forces of tightening FDA regulations and new device introductions have kept the pressure on organizations to step up labeling efforts. Centralized labeling solutions allow manufacturers to keep up with production demands across multiple facilities, an ever more important concern as businesses take on global operations.

Devices including disposable, consumable products are required to have compliant labels, and Transparency Market Research noted that this segment of the market is poised to be the largest and most demand-intensive part of medical device labeling between 2018 and 2025. With businesses of all kinds increasing their fluency in FDA UDI rules, the years ahead promise more labeling and better compliance as manufacturers rise to the challenges they face.

A doctor holds a tray of surgical devices.Single-use medical devices make up the biggest segment of labeling demand.

Industry Participants Feel the Pressure

Plastics Today reported European companies are dealing with the same forces that drove American manufacturers toward more and better labeling. These businesses aim to comply with the EU's Medical Device Regulation (MDR), currently scheduled for 2020. The regulatory picture in the U.S. is unsettled in other ways; while the FDA has sought to simplify its regulatory process, uncertainty around the state of the Affordable Care Act has forced organizations to factor some extra risk into their strategies.

Taken together, regulatory issues are the most talked about challenge in the medical device sector. Plastics Today reported that 68 percent of respondents to Emergo's Global Medical Device Outlook for 2018 survey see rule changes as the No. 1 issue confronting them this year. Dealing with the FDA's requirements and prepping for the next round of EU rulings are essential priorities for any firm in the industry. Having a strong, centralized medical device labeling system is one key way to keep up.

Topics:Medical DevicesRegulatoryTrack & Traceability