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

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Found 9 articles.

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2023 list
Article Update description Date User group
Is your technology a medical device? New content piece added to support developers in determining if their technology is a medical device. November 6 Developers
Data quality considerations for training and testing This page has been updated to include STANDING Together’s Recommendations for diversity, inclusivity, and generalisability in artificial intelligence health technologies and health datasets. November 6 Developers
Planning for evidence generation This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market, and on MHRA's AI-Airlock which will be launched in April 2024. November 6 Developers
Generating evidence for NICE health technology assessment This page has been updated to provide information on NICE Advice, which supports healthtech companies seeking to enter the NHS market. November 2 Developers
Understanding routes to NICE health technology assessment This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market. November 2 Developers
Understanding routes to NICE health technology assessment This page has been updated to provide information on NICE Advice, which supports health tech companies seeking to enter the NHS market. November 2 Developers
Post-market surveillance of medical devices 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 has been updated to reflect the new guidance. July 14 Developers
Determining the intended purpose of your software medical device 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 has been updated to reflect the new guidance. July 14 Developers
Thinking about whether a medical device will meet your needs New guidance added on how to assess whether a medical device will meet your needs. June 7 Adopters