Overview
IMDRF develops harmonized guidance on device classification clinical evidence and postmarket surveillance relevant to imaging modalities.
Modality Relevance
Guidance supports consistent regulatory approaches for CT MRI ultrasound and hybrid devices across member jurisdictions.
Global Impact
IMDRF outputs facilitate regulatory convergence and smoother international device approvals.
Industry and Regulator Use
Manufacturers use IMDRF guidance to design global regulatory strategies for imaging products.