IMDRF Work Items Pile Up

Outcomes from the 13th meeting of the International Medical Device Regulators Forum (IMDRF) in Shanghai last month have continued to trickle out, with a variety of additional work items revealed this week on unique device identifiers (UDIs), adverse event terminology, good regulatory review practices, among others.
 
At the 2018 FDA/Xavier MedCon conference in Cincinnati, speakers from NSF International, Health Canada and Medtronic offered their auditing organization, regulatory authority and industry perspectives at a panel on the updated regulatory convergence efforts.
 
Jackie Elkin, global process owner of standard product identification at Medtronic, expressed great interest in the new UDI application guide—intended to provide an internationally agreed upon application for UDI systems. This work will be led by the EU.
 
Developing the UDI application guide will allow the IMDRF working group to finish the real objectives of the UDI guidance finalized in 2013 as to “operationalize this guidance internally to business and systems,” Elkin said.
 
In addition to the UDI guide, the 10 participating regulatory bodies are inviting stakeholder input on two other new work items on optimizing international medical device standards for regulatory use and on regulated product submissions—led by the US and Canada.
 
“We desperately need industry to be a part of this,” Elkin said. Input is especially needed from multinational device organizations that are dealing with multiple regulatory requirements across the world, she added.
 
From industry’s perspective, Elkin also shared some of the benefits that can be obtained from participating in IMDRF’s work, including increased rate of compliance, enhanced ability to develop global regulatory information management systems with greater harmonization.
 
Although it is being developed by regulators only and led by the US, device companies should pay special attention to the new work on good regulatory review practices, specifically on the revisions to IMDRF’s 2012 essential principles of safety and performance, Kim Trautman, NSF International executive vice president of medical device international services, recommended.
 
This work will result in the addition of essential principles “that can be used as a foundation for creating a more harmonized premarket review process” and it is being developed with the new European regulations on medical devices and in vitro diagnostic devices in mind, Trautman said.
 
Another new regulator-only project relates to previous work on IMDRF adverse event terminology. Two new annexes will be added to the document on this topic to harmonize terms and codes on health effects, meaning what adverse events happened at the patient level, Nancy Shadeed, special advisor at Health Canada’s international programs division, noted.
 
Coordinated by Japan, the work on health effects of adverse events will allow for participating countries to “see how these can be used within the context of IMDRF,” Shadeed said.
 
In addition, Australia is coordinating new work on personalized medical devices, and China’s first work item proposal on clinical evaluations was approved during the Shanghai meeting, as well.