UDI is Here for Class II Medical Devices

March 15, 2016 - Steve Strong, Vice President of Quality and Regulatory Affairs



Effective September 24, 2016, the Unique Device Identification (UDI) becomes a requirement on the labeling for all Class II medical devices following a three year transition period for this class of device. Because the final rules establishing the UDI went into effect for Class III devices in September 2015 and a transition period was provided, many companies have been actively preparing for the upcoming implementation.

What is the UDI?- It is a system used to mark and identify medical devices through distribution and use. The UDI consists of:

  • Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device
  • Production identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the following when included on the label; device traceability (batch, lot, serial number), expiration date, or date of manufacture

The UDI must be both in human readable format and in an automatic identification and data capture (AIDC) technology. This information is applied on the label of each device uniquely identified along with being included on any packaging for the device.

Another key requirement of the UDI regulation is that device labelers must work with a FDA accredited agency to obtain the UDI for their devices. Once the UDI is obtained, the device labelers are required to submit the information to the FDA-administered Global Unique Device Identification Database (GUDID). The GUDID will include a standard set of basic identifying elements for each device with a UDI, and contain ONLY the DI, which provides the key to obtain the device information from the database. PI’s are not part of the GUDID.

Minnetronix has already implemented UDI on the Class III medical devices we currently manufacture. Additionally, we have the technology to verify the AIDC portion of the label. This experience will allow Minnetronix to seamlessly implement UDI on the Class II medical devices.

If you would like learn more about UDI, the FDA’s website: (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm) has a wealth of information including guidance documents and FAQs, or you can contact your Minnetronix representative.