IMDRF publishes updated guides covering governance activities and membership

Regulatory NewsRegulatory News | 20 December 2022 |  By 

The International Medical Device Regulators Forum (IMDRF) recently posted a series of updated guidelines on the group’s standard operating procedures (SOP), criteria for joining, its mission and scope, as well as application forms for joining.
IMDRF is a voluntary group of medical device regulators formed in 2011, and its goal is to accelerate international medical device regulatory harmonization and convergence. Members consist of medical device regulatory authorities from Australia, Brazil, Canada, China, EU, Japan, Russia, Singapore, South Korea, UK and US. The group replaced the Global Harmonisation Task Force in 2012.
The SOP covers the frequency of IMDRF management committee meetings, the composition of the management committee, expedited procedures for joining the management committee, how countries can join as official observers, and how industry members can join as invited observers.
Regarding industry membership, the guide states that “the representatives from the medical device industry, by accepting the invited observer status on behalf of industry, agree to solicit input for the IMDRF [Management Committee] upon request and to take IMDRF outputs back to industry organizations or companies for review and comment during consultation stages.” 
The guide also describes criteria for suspending or terminating membership. It states that “IMDRF Membership suspension may be appropriate if the IMDRF Member is unable to meet its roles and responsibilities… Suspension may also be appropriate if an IMDRF Member, through their behaviour, seriously impairs the proper functioning or reputation of the IMDRF.” 
The guide also discusses procedures for submitting a new work item. This update replaces version 8 issued in March 2021.
The group’s Terms of Reference guide is meant to complement the SOP. Both guides “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.” The document was prepared by the IMDRF management committee.
The also guide covers the mission and the scope of IMDRF, noting that activities and work products may fall into several categories: governance documents, which address procedural and decision-making matters; technical documents, which cover technical issues related to medical device regulation; and information documents, which are meant to clarify or shed light on a particular work item.
An example of a technical guidance was IMDRF’s issuance of guidance on cybersecurity threats issued last May (RELATED: IMDRF proposes legacy device cybersecurity device guidance after stakeholders feedback, 6 May 2022, Regulatory Focus).
The guide also discusses IMDRF’s governance structure, the role of the management committee, the role of the chair, funding, and rules governing confidentiality.  It replaces version 4 issued in July 2018.
The group also released an updated IMDRF application form and an application form for joining a working group.
All the documents were released on 19 December.
IMDRF SOPs; Terms of Reference; Working group application form; IMDRF application


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