The International Medical Device Regulators Forum (IMDRF) is a voluntary group of medical device regulators from around the world who have come together to build on the strong foundational work of the Global Harmonization Task Force on Medical Devices (GHTF) and aims to strategically accelerate international medical device regulatory convergence.
This document complements and is intended to be read in conjunction with the IMDRF Terms of Reference (ToR). It describes the procedures that the IMDRF follows when revising the membership of the IMDRF Management Committee (MC), Official Observers and Affiliates, establishing Subcommittees or Working Groups, developing IMDRF documents or managing documents previously
developed under the GHTF.
The operating procedures outlined in this document, in conjunction with the IMDRF ToR, are designed to be flexible so that should the need arise, the IMDRF can respond to challenges with respect to its objectives in a timely manner.
IMDRF/MC/N2FINAL:2025 (Edition 13 Version 2)
IMDRF Standard Operating Procedures