In 2013, the FDA issued a ‘final rule’ to establish a system to adequately identify medical devices through distribution and use. This final rule requires the label of medical devices to include a unique device identifier (UDI), except where the rule provides for an exception or alternative placement.
During this time the FDA also accredited GS1, a global standards organisation, as an issuing agency to assign Unique Device Identifiers and standards across the industry.
The UDI system will also facilitate healthcare product data synchronisation and accurate reporting of adverse events by making it easier to identify the device. Synchronising healthcare product data globally allows the healthcare industry to know when and where products are produced and to manage recall and adverse event reporting to a global standard.
The FDA mandated UDI regulations and GS1 standards provide a central framework to improve patient safety and enable efficient business processes worldwide.
To comply with the timeline and expectations of the FDA’s final rule on UDI, Exmoor has reviewed its product portfolio and adapted our business processes and systems to meet UDI implementation requirements.
In addition, a new GTIN assignment process has been developed and we have begun labelling some of our products. We aim to have all of our products produced after 31st October 2019 to carry a UDI label.
The UDI label will replace our current unit and shelf pack labels.
Please see examples of our current and new labels below:
|CURRENT LABEL||NEW UDI LABEL|
In response to the introduction of the new UDI label we have reviewed all of our packaging.
New boxes have been designed and you will notice that some products are now packed in larger pouches. This change has been implemented to streamline our packaging stocks and to accommodate the much larger UDI label.
Please see examples of our new boxes below:
The change to packaging is in effect now with all products transitioned over by 31st October 2019.
During this transitional period, some shipments of our products may contain a mixture of old and new packages and labels.
Please be assured that none of these changes will affect the high standard of quality product you normally receive from Exmoor.
If you have any questions regarding the new packaging and label change, please contact us.