Guidance

Machine learning medical devices: transparency principles

Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.

• From: Medicines and Healthcare products Regulatory Agency
• Published: 13 June 2024

Documents

Transparency for machine learning-enabled medical devices: guiding principles

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Transparency for machine learning-enabled medical devices: guiding principles

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MHRA, FDA, and Health Canada have jointly established guiding principles on the transparency of machine learning medical devices. These transparency principles align with previously published guiding principles and offer good practice guidelines on transparency for all medical devices.

Published 13 June 2024