Please note this is an extract of the original bulletin.
Software and artificial intelligence (AI) as a medical device
Page summary:
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Change made:
Updated guidance to include reference to guiding principles on transparency for machine learning-enabled medical devices
Medical devices given exceptional use authorisations during the COVID-19 pandemic
Page summary:
List of manufacturers and their medical devices granted an exemption by MHRA. The list also includes manufacturers whose exemption expired or was cancelled.
Change made:
Updated list of medical devices given exceptional use authorisations
Machine learning medical devices: transparency principles
Page summary:
Guidelines for communicating clear and relevant information about machine learning-enabled medical devices.
Change made:
First published.
