The IMDRF met in September 2024. Topics included regulatory updates, status of Working Group projects, and a stepwise approach to developing effective regulatory systems. As well, the applications accepted for 8 additional affiliate memberships, and for Saudi Arabia as an official observer.

The presentations, including the final meeting statement, are available: HERE

Jurisdictional Updates

The presentations for the following countries were published: Argentina, Australia, Brazil, Canada, China, European Union, Japan, Singapore, South Korea, Switzerland, the UK, and the US. Plus, from the WHO.

• Australian TGA: advised they are better clarifying the definition and exemption criteria for Clinical Decision Support System (CDSS) software; on track to launch a UDI system in early 2025; and in the process of reviewing the feedback from their open consultation on the possibility of e-IFUs for a larger range of professional use medical devices and consumer use devices.  
• Health Canada: provided an update on its ‘New Health Products Shortages Directorate’ and requirements around reporting medical device shortages.
• Singapore HSA: confirmed they are taking a practical approach to UDI Implementation, with no Singapore specific-UDI required. The project is nearing Phase 2 in November 2024, which is the UDI implementation date for all Class D (highest-risk devices), with Phase 3 for Class C devices occurring by November 2026, and Phase 1 for all Class B devices by November 2028.
• UK MHRA: provided a high-level flowchart of its upcoming International Recognition Framework.

Working Group Updates

The following Working Group presentations were published: Adverse Event Terminology,

• Adverse Event Terminology (AET):
  • New documents will be published soon – ‘Common Data Set (CDS) for Adverse Event Data Exchange Guidance Document’, ‘CDS Request form’, and ‘Data exchange file template’
  • A public consultation will be opened for ‘Considerations for the selection of IMDRF Adverse Event Terminology, A Guide for Industry Partners and Healthcare Providers’, along with a webinar to explain the document, similar to the training given September 2023 on ‘IMDRF terminologies for categorised Adverse Event Reporting (AER) – Terms, terminology structure and codes‘
• In vitro Diagnostic devices (IVDs):
  • Plans to update existing GHTF documents on clinical evidence for IVDs, including: 1) GHTF/SG5/N6 (Clinical Evidence for IVD Medical Devices-Key Definitions and Concepts), 2) GHTF/SG5/N7 (Clinical Evidence for IVD Medical Devices-Scientific validity determination and Performance Evaluation), and 3) GHTF/SG5/N8 (Clinical Evidence for IVD Medical Devices-Clinical Performance studies for IVDs)
• Artificial Intelligence/Machine Learning (AI/ML):
  • Public consultation planned for work item ‘Good Machine Learning Practice – Guiding Principles’
  • New Work Item Proposed – AI Lifecycle
• Software as a Medical Device (SaMD):
  • Comments from the public consultant on document ‘Medical Device Software: Considerations for Device and Risk Characterization’ are in process, with plans to publish it early in 2025
  • Plans to draft new guidance on Predetermined Change Control Plans (PCCPs)