UDI: Direct Mark Requirements

Now that the UDI label and GUDID (Global UDI Database) requirement deadlines for class II devices have passed, many manufactures must implement solutions to meet the Direct Mark (DM) requirements for class II devices in 2018. And unlike the label requirements, which “simply” updated the current label with a UDI, the DM requirement often introduces a completely new set of activities, for example, direct part marking, tagging and “permanent” label. Moreover, these activities could affect the safety and effectiveness of the device and may necessitate a new premarket submission. On the other hand, the UDI rule provides for self-exception from the DM requirement if certain criteria are met.

Learn more about the DM requirement, the types of devices that it applies to, the exception criteria, and the different types of solutions available.

The discussion will include:

  • The Direct Mark (DM) requirement
  • DM exception criteria
  • Overview of solutions available
  • Live Q & A session

Who should attend?

  • UDI Team Leaders/Members
  • Regulatory Leaders/Teams
  • Manufacturing, Operations and Supply Chain Logistics
  • UDI IT Support
  • Distributors with UDI Submission Responsibilities

About the Presenters:

Jay Crowley 6Jay Crowley is the Vice President of UDI Services and Solutions at USDM Life Sciences. Jay was Senior Advisor for Patient Safety in the Food and Drug Administration’s Center for Devices and Radiological Health. Jay developed the framework and authored key requirements for the FDA’s Unique Device Identification system.



Grant Hodgkins 4Grant Hodgkins is Vice President of the ERP, PLM and Track & Trace Services and Solutions at USDM Life Sciences.  Grant assists USDM clients with Pharmaceutical Track and Trace, Enterprise Resource Planning (ERP), Product Information Management (PIM), Product Lifecycle Management (PLM), Manufacturing Execution Systems (MES), Unique Device Identification (UDI) and other commercial enterprise solutions.


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