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 |
What's new
Find out what changes have been made to the AI and Digital Regulations Service.
Subscribe