UDI Compliance dates

Below is a summary of the compliance dates for meeting the FDA Unique Device Identification

(UDI) requirements:
24/09/2014 - The labels and packages of Class III medical devices and devices licensed under the Public Health Service Act (PHS Act) must bear a UDI.

24/09/2015 - The labels and packages of implantable, life-supporting, and life-sustaining devices must bear a UDI.

24/09/2016 A Class III device required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if the
device is a device intended to be used more than once and intended to be reprocessed before each use.

24/09/2018 - A Class II device that is required to be labelled with a UDI must bear a UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use.

24/09/2020 - A Class I device, and devices that have not been classified into Class I, Class II, or Class III that are required to be labelled with a UDI, must a bear a UDI as a permanent marking on the device itself if this is a device intended to be used more than once and intended to be reprocessed before each use.

GS1 standards meet all the requirements of the UDI, such as:

Product identification at each level of the packaging hierarchy

The bar code symbols to use

The product data to be included in bar codes

The data that must be stored within the Global UDI Database specified by the US FDA

Barcode Data use partners to deliver the advantages of a secure cloud based solution wrapped within a fixed highly cost effective and easy to understand annual fee. We can help you choose the correct equipment and help design labels and label formats, giving you control to move forward with the UDI Legislation.

 

For further information on how we can help you streamline your business contact us today 0161 330 0077 or sales@bcdata.co.uk

 

 FDA Clasification UDI-Video
 
Unique Device Identification

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