July 2021: Sweden Regulatory Update

Clinical Investigation of Medical Devices

According to an update posted on the Swedish Medical Products Agency (MPA), the national legislation with adaptations to EU regulation 2017/745 on medical devices (Medical Device Regulation) entered into force on 15 July 2021. The transitional requirements for clinical investigations of medical devices as per the new legislation are as follows:

  • All applications and notifications for clinical investigation of medical devices in Sweden must be submitted to the MPA from 15 July 2021, until EUDAMED is fully functional. This also applies for those clinical investigations for which an ethics approval was previously sufficient
  • Combined Submission Dossier: As of 15 July 2021, the ethics application is submitted by sponsor together with the application to the Swedish MPA in a combined submission dossier. The Swedish MPA will, upon receipt of an application or notification, forward relevant parts of the submission dossier to the Swedish Ethical Review Authority for assessment, so no separate submission to the Ethical Review Authority is required. With this new procedure, the sponsor is the applicant also to the Ethical Review Authority
  • Clinical investigations initiated under previous legislation:
  1. Clinical investigations with ethics approval before 15 July 2021 may continue to be conducted in accordance with the provisions in MDR and need not submit an application or notification to the MPA retrospectively.
  2. For clinical investigations with ethics application submitted before 15 July 2021 but no ethical approval in place, sponsors are required to submit a copy of the ethics application and the decision letter from the Ethical Review Authority in the submission package to the Swedish MPA, after the ethical approval has been obtained.

For more details, please refer to Clinical Investigation of Medical Devices.

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