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Specific rules for medical devices

New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.

Writing a final report

For medical technical clinical trials, a final report must be written according to instructions on the Swedish Medical Products Agency's website.

The final report does not need to be submitted to the Swedish Medical Products Agency for trials that have begun before the application of the EU regulation on medical devices (26 May 2021). The Swedish Medical Products Agency may, however, specifically request access to the final report.

Final report for trials that begin after application of the EU regulation on medical devices (26 May 2021) must always be submitted to the Swedish Medical Products Agency.

Guidelines for the content of the report are available in EU regulation on medical devices, Appendix XV and in ISO 14155:2020, 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 and the summary shall be submitted to the Swedish Medical Products Agency one year after the end of the clinical trial, or after three months if the trial was terminated prematurely or suspended.

Publish the results in a public database

Results from clinical investigations of medical devices shall be registered in the public database, where the study was previously registered, regardless of the results. Review whether the journal you intend to publish in has specific requirements for registration in a specific database.