Closed working groups
Closed working groups
Review the GHTF NCAR Exchange Program and to advise on opportunities for improvement
The working group’s mandate was to deliver on Key Terms and Definitions for Machine Learning-enabled Medical Devices.
A working group for Clinical Evidence for IVD Medical Devices
Initiatives undertaken on behalf of the IMDRF Management Committee
IMDRF recognized standards.
Registries of patients undergoing medical device procedures represent a growing potential electronic resource for local and global medical device evaluation and tracking.
Improve the effectiveness and efficiency of the pre-market review process by promoting increased global harmonization.
Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.
Leverage regulatory resources to manage an efficient, effective, and sustainable single audit program.
Harmonize the regulatory requirements for medical devices that are intended for a particular individual, considering unique characteristics and risks associated with each type of device.
Review and update the GHTF/SG1/N045:2008 Principles of In Vitro Diagnostic (IVD) Medical Devices Classification.
Harmonize the format and content of regulatory submissions.
Development of non-binding rules for creating, using, and maintaining unique device identifiers and related activities.
Develop international definitions, risk category framework, and quality management system.
Improve the process of developing international standards used for regulatory purpose in the medical technology domain.
Development of non-binding rules for creating, using, and maintaining unique device identifiers and related activities.