April 12, 2023

UDI for IVD Devices Used In-House: Part 1

The U.S. FDA’s and the IVDR’s requirements for UDI aren’t generally contingent on where the subject device is used.  Instead, the requirements are contingent on the definition of “medical device” and “in vitro diagnostic medical device” (hereinafter “device” / “devices”).  Specifically and plainly, the manufacturer is generally required to assign and maintain unique UDIs for its devices.  A driver for this is the basic intent of the UDI requirements, which is to facilitate device traceability.  The basic need for device traceability is important whether the device is used in-house or out in the field.  Accordingly, regulators would likely push back against the assertion that UDI traceability isn’t value added.  I would steer clear of trying to argue against that.