UDI Compliance: Do Class I Medical Device Manufacturers Need to Do Anything Yet?

Class I medical devices don’t need to be UDI compliant until September 24, 2018. Jay Crowley, former Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health and Vice President of UDI Solutions and Services at USDM Life Sciences, encourages manufacturers of class I medical devices to begin to understand UDI compliance and start to put a plan in place.

Many class I medical device manufactures will need new computer systems or additions to Product Lifecycle Management (PLM) and Product Information Management (PIM) systems. The selection and validation process for new systems can be time consuming.

Medical device manufacturers that distribute class I products outside of the United States should consider meeting the UDI compliance deadline early because some countries will require UDI compliance before the U.S.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.