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Specific rules for medical devices

Writing a final report

When a study requires a permit from the Swedish Medical Products Agency, you must write a final report that is available on request, according to instructions on the Medical Products Agency’s websiteexternal link, opens in new window.

Guidelines for the content of the report are available in ISO 14155, Annex D.

The written final report shall include study data analysed in accordance with what has been previously defined in the clinical trial plan. The final report shall be reviewed by the participating investigators, and the final report shall be signed by the sponsor and principal investigator, or the coordinating investigator for multi-centre studies. The report shall be submitted to the Medical Products Agency on request.