Keeping up with UDI labeling worldwide

by Laura Johnson, on July 17, 2017

Medical device identification deadlines are moving targets.
Medical device identification deadlines are moving targets.

The medical device production field, bound by its unique rules and regulations, is a challenging space for manufacturers to inhabit. For the past few years, the unique device identification (UDI) system has been a matter of constant conversation.

As the concept has evolved, spread around the world and been attached to ever-shifting deadlines, remaining compliant has stayed essential. The following are recent updates on medical device labeling that producers may need to heed depending on their products and markets of choice.

US deadline moves - for some product categories

The Food and Drug Administration's date to achieve UDI compliance has moved a few times since its announcement. According to the National Law Review, it has shifted again - but only for certain device types, ones judged to be low-risk in their potential impact on patients. The new deadlines for affected devices are September 24, 2020 for submission and the same date in 2022 for direct labeling. The source noted that the decision is tactical. By giving the makers of low-danger items two extra years to submit and label their products, the agency will be able to focus on riskier devices.

UDI compliance is on manufactuers' minds in the medical hardware sector.UDI compliance is on manufacturers' minds in the medical hardware sector.

Netherlands approves use of UDI

While the U.S. moves ahead with its UDI plans, another nation has signed onto the registry effort. According to Securing Industry, the Netherlands has become the first European Union country to approve the use of the FDA-styled UDI system for its medical devices. The decision was made to encourage clarity and continuity - and it could signal the beginning of a wider movement toward acceptance of the rules.

Companies have felt the pressure to adopt UDI rules for years now as the U.S. deadlines have loomed. Even with the slight delay, this is still the case. If European countries approve UDI as a standard en masse, the demand for effective product labeling will only grow more intense.

For more on the importance of developing a sustainable UDI labeling program check out our recent webinar "Make UDI Labeling a Program, Not a Project" with Greg Bylo, GS1 US’s VP of Healthcare.

View webinar now

Topics:Medical DevicesHealthcareRegulatoryLabeling