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.