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More information5th October 2026
Summary: The MHRA has updated its published guidance on Good Machine Learning Practice (GMLP) for medical device development. Developed jointly with the US Food and Drug Administration (FDA) and Health Canada, the guidance sets out ten principles to support the development of safe, effective and high-quality medical devices incorporating artificial intelligence and machine learning. The principles address considerations throughout the product lifecycle and provide a framework for manufacturers and developers seeking to incorporate quality and safety into AI-enabled technologies. The principles themselves predate this October update.