Why is UDI important

What is UDI?

Unique Device Identification (UDI) is a system to mark and identify medical devices (via bar codes) by the labeler (e.g. manufacturer, importer, distributor) within the healthcare supply chain.

The U.S. FDA established regulations requiring all medical device suppliers to mark their products with a unique identifier.  This regulation groups devices into three risk classifications (Class I, Class II, Class III) requiring medical device ‘labelers’ to submit UDI information about their products to the GUDID (Global Unique Device Identification Database) – a central repository of device information for public access by healthcare providers and clinicians.

The goal of UDI is to help improve patient safety by enabling better traceability of medical devices consumed.  For the ‘labeler’, UDI will help improve internal processes, bolster master data quality, and provide more accurate reporting and visibility related to product recalls and counterfeit devices.

Why it Matters

With a deadline of September 2020 for Class I devices, these labelers are facing a huge challenge compared to their Class II and Class III counterparts who had to submit much lower volumes of UDI records before September 2018.  Class II and Class III devices were often submitted using manual methods either via direct data entry or Excel spreadsheet uploads to the FDA’s Electronic Submission Gateway (ESG).

While some manufacturers have invested resources to meet regulatory requirements for UDI, data is still far from being effectively managed and used by manufacturers, GPOs and hospitals (healthcare providers).  The sheer volume of Class I products makes manual submission methods too slow and error‑prone, making the risk of failing to meet FDA’s deadline more likely.

Possible Penalties of UDI Non-Compliance include, but are not limited to:

  • Misbranding
  • Seizure
  • Injunction
  • Recall
  • Civil and Criminal Penalties

Next Steps

Talk with the Innovit team about how we can help.  Our UDI Compliance and PIM solutions solve these challenges by allowing device manufacturers to implement a “global system and unified process” that is fully integrated with internal systems to submit product data for multiple UDI recipients simultaneously.

United States FDA: UDI Compliance
HIBCC (Health Industry Bar Code UDI Standards)
GS1 UDI Resource Page
Innovit UDI MultiConnector
UDI Webinar