The Pharma and Medical device industry is well informed on the changes being implemented for better device identification and issue tracking known as the UDI ruling. The first wave of requirements for Class III devices is now behind us and Med Device Online sat down with Jay Crowley, VP and UDI Practice Lead at USDM Life Sciences, is behind the UDI implementation and gave his observations and suggestions. Below are some key points.
Observations and issues:
Manufacturer’s aren’t sure of all UDI compliant products they produce.
Device classification for a product may have changed over the years
Who is the “Labeler”? The OEM, distributor, packager or contract manufacturer?
Many companies are using UDI implementation as a complete infrastructure change.
Define every device your company manufactures and narrow down those that are UDI compliant.
Plot your devices purpose and market to better classify the product.
As the “Labeler” you need to define a process for compliance among all of your suppliers involved in UDI devices.
Confirm your barcode meets at least a “C” grade quality standard.
Do not implement excessive or unnecessary changes to make UDI changes a more daunting task.
Some very simple but great advice that can be used in further UDI implementations and also for manufacturers who have not met the requirements. To view the full article click the link below.