International Medical Device Regulators Forum (IMDRF)
International Medical Device Regulators Forum
We strategically accelerate international medical device regulatory convergence to promote an efficient and effective regulatory model for medical devices that is responsive to emerging challenges while protecting and maximizing public health and safety.
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
Seeking to establish a comprehensive set of IMDRF documents as a reference for members and stakeholders in developing their regulatory frameworks, while supporting continued global harmonisation
Develop good review practices for pre-market reviews and evaluations.
Ensure alignment of IMDRF QMS and risk management documents with current international standards
Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.