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Class III Medical Devices; News and Information


The first compliance date for Unique device identification, UDI, class III was September 2014. Class III medical devices are defined as devices that support or sustain human lives, Class III Medical Devices include implanted pacemakers, heart valves and implanted cerebral simulators.

At that time the FDA mandated that labels and packages of class III medical devices that would be placed into commercial distribution throughout the US, must bear a UDI. An exception to this rule was that all devices that were manufactured prior to this compliance date were granted a 3-year grace period to comply. This exception applies to both products held in inventory by the labeler and those consigned to a hospital or other potential purchaser and held in inventory, but not yet purchased, by the potential purchaser.

Three years later, 2017 has arrived, and medical manufactures still have class III devices in their inventory with non-compliant labels. In September of this year, these items must have proper UDI marking. This inventory management challenge creates the need for a process that has been called UDI inventory remediation. This process will allow for organizations to remedy their UDI class III inventory in time to meet the deadlines.

Pragmatyxs has years of experience working with medical manufactures to be sure all products meet the FDA UDI labeling requirements. Please contact us if you require any assistance on your product labeling needs.