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Specific rules for medical devices

Medical devices are in the EU regulated by two categories that follow different regulations:

  • For medical devices, the EU Regulation on Medical Devices (MDR) applies. New rules apply within the EU from 26 May 2021, additional rules apply in Sweden from 15 July 2021.
  • For in vitro diagnostic medical devices, the EU Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) applies. New rules apply within the EU from 26 May 2022.

Medical devices, EU regulation MDR

 

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 an easy-to-understand summary shall be submitted to the Swedish Medical Products Agency latest one year after the end of the clinical trial, or latest 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.

Medical devices for in vitro diagnostics, EU regulation IVDR


Writing a final report
For clinical performance studies on in vitro diagnostic products, a study report must be written in accordance with the EU regulation on medical devices for in vitro diagnostics, Annex XIII, Part A section 2.3.3 and Annex A in ISO 20916: 2019.

A study report must be signed by a doctor or another responsible competent person and must, among other things, contain results and conclusions of the study, including negative results. The report shall contain so much information that an independent party shall be able to understand it without reference to other documents.

The report and an easy-to-understand summary must be sent to the Swedish Medical Products Agency within one year after a clinical performance study has been completed or no later than three months after it has been terminated prematurely or temporarily interrupted.

Publish the results in a public database
Results from clinical performance studies must be recorded 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.

EU regulation on in vitro diagnostic medical devices External link.

ISO 20916: 2019, SIS website External link.