How It Would Work The GHTF advocates a global UDI system incorporating three main elements. Firs

How It Would Work

The GHTF advocates a global UDI system incorporating three main elements.

First, any UDI system established by a market regulator must adhere to a globally accepted standard. Second, UDIs should be attached either on devices themselves or on product labels. Finally, UDI data should be submitted properly to the UDID to ensure the database’s accuracy.

Other key recommendations:

• UDI system participants must ensure they each properly capture and store individual UDIs throughout their associated devices’ distribution and use time frames in order to meet traceability goals;

• UDI marking on devices should constitute an additional labeling requirement—they would not replace any other labeling information;

• Creation and maintenance of UDIs should be the responsibility of medical device manufacturers;

• Automatic Identification and Data Capture methods required by national regulators should be based on ISO standards approved by the UDI Standards Development Organization;

• Manufacturers should be responsible for submitting and updating UDI information in the UDID; and

• UDI data should include Global Medical Device Nomenclature (GMDN).