62/474/NP Machine Learning-enabled Medical Device – Performance Evaluation Process

Comment period start date: 16/08/2023 Comment period end date: 03/10/2023 Scope This document defines a standardized performance evaluation process for Machine Learning-enabled Medical Devices (MLMD). The set of processes, activities, and tasks described in this document establishes a common framework for MLMD performance evaluation. Purpose The evaluation of ML performance is a crucial factor in measuring the overall MLMD’s performance.…