UDI Compliance: The Key Dates

by Francine Harris | June 11, 2018 | Blog

In 2013 the Food and Drug Administration issued a final rule setting out a system for Unique Device Identifiers, or UDIs, that should be applied to medical devices.

These UDIs must be in both plain text and a format that can be read by a machine, such as a bar-code. The codes record both information about the model of the device, but also information about its date of manufacture, expiration date, and other important data.

When the final rule was established, it set out a time-frame for compliance with the requirements. This laid out what steps had to be taken and by what dates. Read more to learn about the key dates for UDI compliance.

The FDA Compliance Dates

The dates for UDI compliance as set out by the FDA are as follows.

24th September 2014

All class 3 medical devices and stand-alone software need to have a unique device identifier by this date. The final rule sets out the specific formatting that the dates included on the UDIs must use. The information about these devices has to be sent to the GUDID database. It was possible to request an extension of this compliance by one year.

24th September 2015

This is the deadline for implantable devices and standalone software to be given a unique device identifier. It includes both life-sustaining and life-supporting devices and software. Once again, the dates on the UDIs must meet the requisite formatting. The information about these devices has to be sent to the GUDID database.

If the devices are reusable, the UDI must be marked on the device in a permanent way such that it remains in place when the device is processed for reuse.

24th September 2016

By this date, all reusable class 3 devices need to have a unique device identifier. The UDI must be permanently marked on the device so that it remains in place when the device is processed for reuse.

Class 2 devices and stand-alone software must also have a unique device identifier on their labeling and packaging. The final rule sets out the specific formatting that the dates included on the UDIs must use. The information about these devices has to be sent to the GUDID database.

24th September 2018

By this date, all reusable class 2 devices need to have a unique device identifier that is permanently marked on the device so that it remains in place when the device is processed for reuse.

Any devices or stand-alone software that are either class 1 or have not been classified require a unique identification number. The final rule sets out the specific formatting that the dates included on the UDIs must use. The information about these devices has to be sent to the GUDID database.

24th September 2020

The final stage of compliance is that by this date all reusable class 1 devices and devices that have not been classified need to have a unique device identifier that is permanently marked on the device so that it remains in place when the device is processed for reuse.

Looking for help with UDI compliance?

If you are looking to achieve UDI compliance for your business then you’ve come to the right place.

We offer a UDI compliance solution designed for device manufacturers. It will help you overcome the challenges of having to submit product data to a range of international regulatory agencies.

If you would like to learn more about how we can help, as well as the other great MDM systems we can offer the healthcare industry, then please don’t hesitate to get in touch.

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