IMDRF Technical Framework for Artificial Intelligence Life Cycle Management
| Issuing Body | International Medical Device Regulators Forum (IMDRF): Artificial Intelligence/Machine Learning-enabled Working Group |
| Opening Date | 10/04/2026 |
| Closing Date | 10/07/2026 |
| Status | Closed |
| Consultation Website | https://www.imdrf.org/consultations/technical-framework-artificial-intelligence-life-cycle-management |
The International Medical Device Regulators Forum (IMDRF) has opened a public consultation on its draft document N93: Technical Framework for Artificial Intelligence Life Cycle Management, developed by the IMDRF AI/ML-enabled Working Group.
The consultation invites feedback from industry and other stakeholders on a proposed framework governing the development, deployment, and ongoing oversight of AI/ML-enabled medical devices across their full life cycle.
If you would like MTAA to provide feedback, please email lwaheed@mtaa.org.au by COB Friday 3 July, including i) the section and line number to be changed, and ii) the specific change you are proposing, with details.
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