Skip to main content
UK Government Updates Regulatory Affairs NewsletterUK Government Updates Regulatory Affairs Newsletter Archive

MHRA and international partners publish guiding principles for machine learning-enabled medical devices

By October 27, 2023No Comments

MHRA, U.S. Food and Drug Administration (FDA) and Health Canada have jointly released ‘Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles

In this document, MHRA, FDA and Health Canada have jointly identified 5 guiding principles for predetermined change control plans (PCCP). These principles draw upon the Good Machine Learning Practice (GMLP) guiding principles. PCCPs provide a new method for managing rapid product changes often seen with Software and Artificial Intelligence products. These guiding principles will help to ensure alignment between jurisdictions on PCCPs and products utilising them.