Your passport to UDI compliance and a world of opportunity:

Recent FDA legislation has changed the rules for tracking and tracing medical devices, from September 2016 these rules impact the UK and Europe where devices are manufactured for the healthcare market.

As experts in solutions for product identification and the needs of the healthcare industry Bar Code Data understand the implications this legislation has on your business, we can be there to help you determine compliance into existing opportunities.

FDA legislation now means that from the start of manufacture right through to when goods are shipped all part are tracked and traced to safeguard quality and compliance.

All medical devices must now carry a unique device identifier or UDI label it must be readable and scan-able from the point of production during shipment through the products appropriate use and finally to its disposal.

A UDI makes important information easily accessible and helps to ensure compliance traceability efficiency and patient safety.

The supply chain begins at the manufacturer where a bar code is printed on the device or diagnostic packaging.

Device labellers also need to submit information about the product to a database administered by the FDA inside the package is a

Global Trade Item Number GTIN which makes re-ordering or diagnostic tests easier and makes the device journey easier to track.

The UDI also helps to tackle product counterfeiting and helps achieve patient safety so if there is a product issue the devices and diagnostic that need to be recalled can easily be identified.

This brings challenges, however, Bar Code Data in partnership with Zebra can help turn these challenges into opportunities.

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

• Compliance  Dates

• Falsified Medicines Directive

• Device Classes