UDI Implementation Steps

The timeline for complying with the Unique Device Identification (UDI) rule issued by the U.S. Food and Drug Administration (FDA) is based on the classes of medical devices. Highest risk devices (class III) will be brought into the fold of the UDI system first, within the first year of the final rule. By 2020, all classes of medical devices are projected to be in compliance with the UDI rule.

So while complete implementation is around seven years away, manufacturers need to initialize their implementation activities right now. The pervasive UDI implementation warrants a well thought-out implementation strategy that enables medical device manufacturers to make the most of the new device identification system that is emerging. From clinical to supply chain benefits, there are ample advantages of streamlined implementation for manufacturers.

High-level UDI implementation list for medical device manufactures

  1. Identifying the FDA requirements applicable to the manufacture’s devices.

  2. Conducting a gap analysis between their existing quality system and FDA requirements.

  3. Developing a Quality Plan for UDI implementation.

  4. Obtaining membership of an FDA-accredited issuing agency. Currently GS1 and HIBCC received accreditation.

  5. Choosing a label printing system, and a device marking system if applicable.

  6. Designing and acquiring package label stock(s) with primary printing.

  7. Selecting a barcode style to be used on the device packages and/or the devices themselves  as relevant. Barcode language dependent on numbering organization selected.

  8. Choosing barcode style to be employed on package labels and/or device itself.

  9. Designing  “artwork”, essentially a secondary label on the devices. The same is applicable on direct device markings as relevant.

  10. Establish barcode quality verification program.  Programs should be standards based and allow for traceability.

  11. Updating Quality System documents to incorporate UDI implementation.

  12. Validating the UDI application processes (protocol, execution, report).

  13. Substantiating implementation readiness as per Quality Plan.

  14. Entering UDI data into Global Unique Device Identification Database (GUDID).

After Going Live

Once a manufacturer and/or labeler has completed the UDI  implementation steps, it is a good idea to educate customers about the implementation.  An efficient way of doing this would be by publishing a user-friendly product catalog cross-referencing Device Identifier numbers with REF/Catalog numbers.

The complete adoption of the Unique Device Identification System will require efforts on multiple fronts.  Rather than handling as a single project, this needs to be broken down into various components.