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This page focuses on regulatory updates from the EU, U.K. and the U.S. Click on the relevant flag for more information. Updates from other jurisdictions are not actively monitored but the current situation regarding SaMD regulation in the following locations can be assessed by visiting the relevant website:
You should also be aware of the Medical Device Single Audit Program (MDSAP), which is essentially a mutual recognition arrangement aimed at avoiding unnecessary duplication of auditing activities. The following countries are currently signed up to MDSAP: Australia, Brazil, Canada, Japan and the United States.
For more information on how the various regulatory authorities are planning to deal with medical device software in general, and AI-enabled medical device software in particular, see the Current thinking page.
This page was last updated: 23 Sept 2025
