Title: Recommended Practice for Performance Monitoring of Machine Learning-enabled
Medical Device in Clinical Use
Scope: The recommended practice describes a framework to monitor the
performance of machine learning-enabled medical device (MLMD) in clinical use. The framework describes
requirements, metrics, methods and procedures to implement performance monitoring.
Purpose: The purpose of this recommended practice is to define a framework that can be used by
stakeholders to keep track of performance of MLMD in clinical use and provide information for post-market
surveillance, technical vigilance and product changes.
PAR Approval Date: 21 Sep 2022
PAR Expiration Date: 31 Dec 2026
The approved PAR is attached below: