Work Package 2 will evaluate how evidence should be generated for innovative medical devices during first-in-human studies and early clinical trials. New methods of generating evidence will be considered and methods for evaluating high-risk devices for children will be assessed. Guidance for the evaluation of artificial intelligence in medical devices and standalone software as a medical device will be reviewed and developed.

Objectives

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To review and recommend alternative designs of clinical studies that can be used to provide high-quality clinical evidence for new high-risk medical devices

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To conduct feasibility studies of using the IDEAL framework in the early stages of device clinical testing

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To survey existing guidance and recommend criteria for the clinical evaluation and regulatory conformity assessment of artificial intelligence and machine learning in high-risk medical devices

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To review and recommend methods for evaluating high-risk medical devices used in children