Posted 08 September 2015
By Zachary Brennan
In anticipation of the International Medical Device Regulators Forum (IMDRF) stakeholders meeting in Japan next week, participating countries’ regulators, trade groups and others have outlined a number of updates they plan to share.
Begun in 2011, IMDRF is a voluntary group of medical device regulators from Australia, Brazil, Canada, China, EU, Japan and the US, as well as the World Health Organization (WHO), with the aim of accelerating international medical device regulatory harmonization and convergence.
The group, which has met seven times since its inception, provides updates on members’ respective and evolving regulations.
Currently, IMDRF is consulting on three topics, which include common data elements for medical device identification, a short survey to help stakeholders understand the applicability of current guidance related to Software as a Medical Device (SaMD), and a request for expressions of interest to participate in the IMDRF Table of Contents pilot plan.
Next week, IMDRF’s Management Committee, which meets bi-annually, will come together in Kyoto, Japan to offer updates from the US, EU, Japan, Canada and Brazil, as well as to offer more information on the activities of IMDRF working groups, the Asian Harmonization Working Party and other industry groups.
Based on the presentations posted online Monday, Jeff Shuren, director of the US Food and Drug Administration (FDA)’s Center for Devices and Radiological Health (CDRH), plans to offer participants an update on CDRH strategic priorities, as well more information on so-called “breakthrough devices,” which offer a potentially significant public health benefit because they are intended to treat or diagnose patients with life-threatening or irreversibly debilitating conditions whose medical needs are unmet by current technology.
“Some data collection for devices marketed under this pathway might be moved from pre- to postmarket, provided there is still a reasonable assurance of safety and effectiveness concerning the device,” according to a slide in Shuren’s presentation.
Shuren may also discuss device issues that would be addressed by the 21st Century Cures Act, which passed the US House of Representatives in July. That legislation includes provisions tied to priority review for breakthrough devices, third party quality system assessment, easing the regulatory burden with respect to certain class I and class II devices and other provisions that the US Senate is currently working on.
The presentation from the European Union will come from Erik Hansson, deputy head of unit of the European Commission, who will focus on revisions of the EU medical device legislation, which is expected to be adopted by the European Council at the beginning of next month, and fully adopted by the end of 2015 or the beginning of 2016.
Other issues Hansson plans to discuss include the pre-market control of high-risk medical devices and the reprocessing of single-use devices.
Irena Prat of WHO is expected to discuss the streamlined prequalification of IVDs, the variable compliance and significant work load for the prequalification of diagnostics, and the need for international harmonization on this topic.
In addition, Prat will discuss global trends around regulatory device frameworks and WHO’s Ebola-related efforts.
Representatives from the Pan-American Health Organization, Asia-Pacific Economic Cooperation, Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association and Asian Harmonization Working Party are also expected to provide presentations at the meeting.
In addition, a general affairs session will discuss the implementation of IMDRF’s unique device identifier (UDI) guidance. It is expected that each jurisdiction involved in IMDRF will introduce a universal UDI system according to the guidance in the implementation.