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Specific rules for medical devices

New rules apply from 26 May 2021 - but some are delayed (preliminary) until 15 July 2021. Updates regarding the rules from 15 July will be published early autumn.

Writing a final report

A final report shall be written together with an easy to understand summary according to instructions on the Swedish Medical Products Agency’s website.

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.

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.