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Is my software regulated?

Guidance

Flowcharts showing which software products are regulated as a medical device, and those that are not.

Last updated

27 July 2021

Flowcharts showing which software products are regulated as a medical device, and those that are not.

Contents

How do I know if my software is a medical device?
What if I need more information?
Is my software regulated?
Is its purpose likely to be medical?
Is it excluded?
Is the clinical decision support software exempt?

Supporting documents

Is my software regulated? [PDF, 84.94 KB]

Topics