IMDRF publishes new procedures on membership, governance
The International Medical Device Regulators Forum (IMDRF) recently updated its procedures for membership and for developing and managing technical guidelines.The 40-page Standard Operating Procedures (SOP) document was prepared by the group’s Management Committee. The guide is intended as a complement to the IMDRF Terms of Reference (ToR) and describes the procedures for revising the membership of the IMDRF Management Committee, establishing subcommittees and working groups, and developing IMDRF documents or managing documents developed under the Global Harmonization Task Force on Medical Devices (GHTF).
Both the SOP and the ToR documents are meant to be flexible to allow IMDRF to promptly respond to challenges. This document replaces a previous version issued in December 2022 (RELATED: IMDRF publishes updated guides covering governance activities and membership, Regulatory Focus 20 December 2022).
The SOP document addresses criteria for membership, engaging with IMDRF, the steps for developing technical documents, the management and maintenance of GHTF documents. Three annexes explore the IMDRF’s organizational structure, membership roles and criteria for suspension and termination of membership.
IMDRF, which was established in 2011, is a group of global medical device regulators whose aim is to speed the adoption of international medical device regulatory harmonization and convergence. Original members include health authorities from Australia, Brazil, Canada, China, European Union, Japan and the United States and the World Health Organization (WHO).
The IMDRF consists of the Management Committee, official observers that include regulatory authorities, and the WHO. Regulatory authorities that would like to engage with IMDRF, but do not wish to become members, may apply to become affiliate members.
IMDRF Management Committee members, official observers and affiliates may have their membership suspended or terminated by the IMDRF Management Committee if a member is unable to meet their roles and responsibilities. The SOP details the process for voting and suspension. Members may voluntarily withdraw from IMDRF at any time.
The SOP document states that “IMDRF membership termination may be appropriate if an IMDRF Member is unable to adequately address the issues identified in a Suspension Notice. In circumstances where it is brought to the IMDRF [Management Committee’s] attention that behaviour of an IMDRF Member egregiously is unable to meet its role and responsibilities or if the IMDRF Member’s actions extremely and critically impairs the proper functioning or reputation of the IMDRF, IMDRF Membership may be terminated prior to suspension.”
The Management Committee agreed to the proposed updates following its 28 September 2023 meeting in Berlin.
IMDRF guidance on operating principles
