Survey: Most Devicemakers Still Need to Prepare for UDI Requirements

August 29, 2016

Only about 15 percent of device manufacturers of Class II and Class III devices are currently compliant with new unique device identifier requirements that take effect Sept. 24, according to a recent survey.

Roughly half of the 120 medical device companies polled hadn’t even conducted internal audits, and 53 percent said they would need additional support for their UDI processes to meet the regulatory requirements.

The survey—which polled 120 medical device industry professionals responsible for regulatory, IT and labeling—showed that 93 percent reported that UDI requirements have had a major or at least noticeable impact on their existing labeling processes.

Only half of respondents felt that their current barcode labeling software solution would be able to scale up to meet long-term UDI regulations and other evolving international requirements, according to the survey conducted by Loftware and USDM Life Sciences. — Tamra Sami

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