IMDRF Clinical Documents for Public Consultation


The International Medical Device Regulators Forum (IMDRF) is a forum for regulators to discuss directions in medical device regulatory harmonization. It consists of a group of medical device regulators from around the world* to accelerate international medical device regulatory harmonisation and convergence.

As part of this work, the IMDRF Medical Devices Clinical Evaluation Working Group (MDCE WG) have released the following documents for stakeholder consultation and comment templates on the IMDRF website:

  • Clinical Evaluation - IMDRF MDCE WG (WD)/Nx (formerly GHTF/SG5/N2R8:2007)

  • Clinical Evidence - Key Definitions and Concepts – IMDRF MDCE WG (WD)/Nx (formerly GHTF/SG5/N1R8:2007)

  • Clinical Investigation - IMDRF MDCE WG (WD)/Nx (formerly GTHF/SG5/N3:2010)

*IMDRF member countries are Australia, Brazil, Canada, China, Europe, Japan, Russia, Singapore, South Korea and USA.

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