Jackie Elkin, Global Process Owner Standard Product Identification with Medtronic, U.S., provided an overview of the Global Medical Technology Alliance’s (GMTA) work item proposal to the International Medical Device Regulators Forum (IMDRF) and the resulting content of the draft UDI Application Guide.
The GMTA is comprised of national and regional medical technology associations with members from more than 85% of the world’s medical device and diagnostic equipment manufacturers. GMTA developed and presented a work item proposal to the IMDRF management committee, which was accepted unanimously.
The work item is an application guide that would supplement the original guidance, which was finalised in 2013 and provided phase one, foundational guidance, yet did not include the detail needed for a harmonised approach.
The purpose of the UDI Application Guide is to provide a single reference for facilitating the implementation of UDI with a globally harmonised approach. The resources that will support further development of guide include the original IMDRF work group with the European Commission accepting the position of work group chair.