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Find out what changes have been made to the AI and Digital Regulations Service.

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2023

Article Update description Date User group
Monitoring medical devices once they have been deployed The MHRA has published new guidance on reporting adverse incidents involving Software as a Medical Device under the vigilance system. The content on our website is under review and will be updated to reflect the new guidance. May 2023 Developers
Writing the intended purpose statement for medical devices The MHRA has published new guidance on crafting an intended purpose in the context of Software as a Medical Device. The content on our website is under review and will be updated to reflect the new guidance. March 2023 Developers

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