Working groups
Working groups
Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.
Seeking to harmonize internationally, principles to help promote the development of safe and effective AI/ML enabled medical devices
A working group on Clinical evidence for in vitro diagnostic (IVD) medical devices
Develop good review practices for pre-market reviews and evaluations.
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.
Ensure alignment of IMDRF QMS and risk management documents with current international standards
Harmonize the format and content of regulatory submissions.
Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.