Guidance
Clinical investigations: statistical considerations
How to make sure that you are providing the statistical data required as part of a clinical investigation of your medical device.
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Details
This guidance helps manufacturers to understand the statistics that should be included as part of the data gathered during a clinical investigation. It includes information about:
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clinical investigation design
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conduct and monitoring phase
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follow-up and reporting
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safety issues
Updates to this page
Published 30 March 2026