Slowly but surely, the Unique Device Identification (UDI) System topermit global identification and tracking of medical devices is moving from concept to implementation. UDI’s potential benefits are irrefutable in terms of better post-market surveillance, vigilance and other issues, but the actual implementation of such a system poses considerable logistical challenges—and requires buy-in from all major market regulators in order to properly function.
While substantial, the challenges do not appear to be an obstacle to medical device industry regulators establishing a functioning UDI system. If successful, the ramifications of such an effort will truly be significant for industry participants and regulators alike. The market regulators collectively making up the Global Harmonization Task Force (GHTF) have issued final guidelines on how national authorities should go about setting up systems that support a harmonized global UDI infrastructure, and the U.S. Food and Drug Administration (FDA) is developing draft regulations for implementation of a UDI system in the United States.
In addition, the European Commission heads a GHTF ad hoc working group developing guidelines to ensure that the FDA’s UDI proposal will be compatible across global markets. Of course, therealso is interest to ensure that the Asian Harmonization Working Party is part of the GHTF’s activities. With such heavy regulatory weight behind a global UDI system, the question of implementation increasingly becomes when, not if.