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Clinical investigations initiated under previous legislation

  • Published: July 15, 2021
  • Last updated: July 15, 2021

The regulatory framework for clinical investigations of medical devices changed when the EU regulation 2017/745 on medical devices (MDR) was implemented on 26 May 2021. The national legislation with adaptations to MDR entered into force on 15 July 2021. Below is a summary of the transitional requirements for clinical investigations initiated under the previous legislation.

What applies for notifications and applications made before the new legislation entered into force?

Notifications regarding clinical investigations that were submitted to the the Swedish Medical Products Agency (Swedish MPA) before the MDR date of application (i.e. 26 May 2021) are handled by the Swedish MPA in accordance with the directive’s legislation i.e. the act Lagen (1993:584) om medicintekniska produkter and the Swedish MPA’s provisions Läkemedelsverkets föreskrifter (LVFS 2003:11) om medicintekniska produkter or Läkemedelsverkets föreskrifter (LVFS 2001:5) om aktiva medicintekniska produkter för implantation as applicable.

These investigations can, provided that they are authorised (which is communicated by the Swedish MPA within 60 days of receipt of a valid notification), be initiated and continue to be conducted in accordance with the directive’s legislation.

This means that the provisions in MDR on substantial modifications, temporary halt, premature termination, end of study and study report do not apply for these investigations, they are to continue following the LVFS 2003:11 or LVFS 2001:5 depending on device type. However, the safety reporting requirements of the MDR apply for these investigations.  

Clinical investigations that were not subject to the Swedish MPA notification requirements before 26 May 2021 and for which there was an ethics approval before 26 May 2021 can be conducted in accordance with the directives legislation and do not have to be submitted to the Swedish MPA retrospectively.

This applies even if the recruitment of subjects has not commenced before 26 May 2021. For these investigations, safety reporting to the authorities shall comply with the provisions that apply for products placed on the market.

Clinical investigations that did not have to be submitted to the Swedish MPA under the MDR before 15 July 2021 but for which an application or notification to the MPA would be required according to the national legislation that applies from 15 July 2021 may continue to be conducted in accordance with the provisions in MDR, provided that there was an ethics approval in place before the 15 July 2021. There is no need to submit an application or notification to the Swedish MPA retrospectively.  

If an ethics application was submitted before 15 July 2021, but ethical approval was not in place by 15 July 2021 when the new national legislation entered into force, the handling process at the Swedish Ethical Review Authority may proceed, but when the ethical approval has been obtained an application or notification shall be made to the Swedish MPA. A copy of the ethics application and the decision letter from the Ethical Review Authority shall be included in the submission package to the Swedish MPA. If no substantial modifications are made to the study documentation, there is no need for an additional ethics review.