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

Harmonize terminology for reporting adverse events related to medical devices, and further harmonize adverse event reporting datasets to improve signal detection.

A working group on Clinical evidence for in vitro diagnostic (IVD) medical devices

Ensure alignment of IMDRF QMS and risk management documents with current international standards

Seeking to harmonize internationally, principles to help promote the development of safe and effective AI/ML enabled medical devices