Design & Concepts, Labels, Packaging Equipment, Packaging Material, Specialised Packaging, Technology

Direct Marking for FDA UDI Compliance

By Microscan

Direct marking is an important component of the FDA Unique Device Identification (UDI) regulation. The purpose of UDI is to establish a standard method for identifying and tracing medical devices throughout their lifecycles, from production, to distribution, to use.

For medical devices that are reused many times during their lifecycles, a UDI must be able to withstand any amount of handling or reprocessing.

The most reliable way to ensure a UDI lasts the lifecycle of a multi-use device is by affixing a permanent mark to the device itself, rather than a temporary package or label.

Direct part marking (DPM) is not a new concept in industrial manufacturing, but is relatively new territory for medical device identification.

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