Work package 2- New methods for generating clinical evidence

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

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

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

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