UDI Labeling

In the United States, the US Food and Drug Administration requires that all medical devices distributed in the United States. carry a Unique Device Identifier (UDI) label. Based on these regulations, medical devices including Class I, II, and III devices, InVitro devices, software, and some tissue-based products must include UDI labeling. UDI medical device labeling must be approved by the FDA through an accredited organization; it is not a self-generated code invented by your company.

UDI labeling must be both machine-readable and human readable and must contain the device identifier (DI) and the production identifiers (PI). Chances are, if your product does not already display UDI labeling, you will need to redesign your labels to make them compliant.

UDI Labeling Levels: Imprint Enterprises

UDI Medical Device Labeling Classifications

What is a Medical Device?

Medical devices fall into one of the following three descriptions.

It is an instrument, apparatus, implant, in vitro reagent, or similar or related article.
It is used to diagnose, prevent, or treat disease or other conditions.
It does not achieve its purposes through chemical action within or on the body (which would make it a drug).

UDI Medical Classifications: Imprint Enterprises

Class III Devices

Support or sustain human life.
Are of substantial importance in preventing impairment of human health.
Present a potential, unreasonable risk of illness or injury.
Examples: implantable pacemaker, pulse generators, HIV diagnostic tests, automated external defibrillators, etc.

Class II Devices

General controls alone cannot assure safety and effectiveness
Existing methods are available that provide such assurances
Examples: powered wheelchairs, infusion pumps, surgical drapes and an implantable radiofrequency transponder system for patient identification and health information

Class I Devices

Not intended to help support or sustain life
Not intended to be substantially important in preventing impairment to human health
May not present an unreasonable risk of illness or injury
Examples of Class I devices include elastic bandages, examination gloves, and hand-held surgical instruments

UDI Medical Device Labeling Levels

Because UDI labeling must remain intact and readable over the lifetime of the device, it’s imperative that you rely on an experienced company, like Imprint, to guarantee compliance. Some of the unique considerations that need to be taken into account include surface material of the product as well as shape of the surface. Environmental conditions are also a concern, as devices may be exposed to very low or very high temperatures, humidity, and chemicals.

Direct Marking – Level 1

Class III LS/LS devices must bear a permanent UDI label by September 24, 2015. All other class III devices must bear a permanent UDI label by September 24, 2016.

Device Packaging – Level 2

If a device is intended to be used more than once and intended to be reprocessed before each use, the device must have the UDI label permanently marked on the device itself. A single-use device may have the UDI label marked on its packaging.

Inner and Outer Cartons – Levels 3 and 4

Generally speaking, UDI labels must be placed on both the product and the packaging. What is marked depends on how the device will be consumed and if it is reusable. The UDI does not have to be on the shipping container (i.e., skid or tote).

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