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Machine Learning-enabled Medical Devices - A subset of Artificial Intelligence-enabled Medical Devices: Key Terms and Definitions

A Proposed Document by the International Medical Device Regulators Forum (IMDRF) Artificial Intelligence Medical Devices (AIMD) Working Group is provided below for public comment.

This consultation closed on Monday, 29 November 2021.

Working Group Chair: Dr. Young-kyu Kang, South Korea

Thank you for your contribution aiming at the validation of the IMDRF document.

Consultation documents

Please use the comments template to provide comments on the Proposed Documents and send comments to Dr. Young-kyu Kang via e-mail: with the subject line 'Public Consultation on Proposed AIMD Working Draft'