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

24th October 2023

The Medicines and Healthcare products Regulatory Agency (MHRA), US Food and Drug Administration (FDA) and Health Canada have collaborated to identify five guiding principles for the development of predetermined change control plans (PCCPs). These guiding principles for PCCPs aim to remove the regulatory burden for developers of machine-learning-enabled medical devices (MLMDs), enabling reallocation of resources to improve product performance for patients.

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