Washington – 7 June 2023
DITTA announces today the release of its new White Paper on Unique Device Identification: “Challenges with Implementing Global Unique Device Identification Requirements and Solutions”.
While the purpose of a global UDI system is to increase transparency and standardization, the current variability of its requirements and implementation globally is causing challenges for medical device manufacturer supply chain compliance.
These issues affect traceability of medical devices, adverse event reporting, global data sharing and transparency, and ultimately result in inefficient processes, higher costs and a decrease of patient safety.
The DITTA White Paper describes some of the challenges and inconsistencies experienced by industry and provides recommendations to the International Medical Device Regulators Forum (IMDRF), Regulators and Medical device manufacturers.
The recommended improvements for a global UDI system require harmonization opportunities focusing on people, processes, and master data management.
DITTA Chair Patrick Hope says, “We are proud to announce the release of our latest White Paper, which brings industry’s proactive and pragmatic contribution to the IMDRF working group. The paper provides valuable insights which, when implemented, will improve adoption and usage of UDI requirements. A harmonized, global UDI system will ultimately benefit all health care institutions.”
For more information, contact:
MITA, Executive Director