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.

Manage cybersecurity risks in medical devices through a life-cycle approach. Striking the right balance between pre-market and post-market requirements.

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.
Doctor holding AI Slide on Virtual Screen

Promote consistency in regulatory assessment for Software as a Medical Device to reach patients more efficiently.