CTU Bern

New legislation – Clinical Investigations with Medical Devices

On 26th May 2021, the European Regulation (EU) 2017/745 on medical devices (MDR) will become fully applicable

10.05.2021 – As a consequence, the legal requirements for clinical investigations with medical devices are changing.

These requirements are transposed into Swiss law through an update of the Human Research Act (HRA) and its ordinances, including the new Ordinance on Clinical Investigations with Medical Devices (ClinO-MD), that will come into force on the same date.

Ongoing Clinical Investigations:

Approvals for ongoing clinical investigations from the competent EC(s) and Swissmedic delivered before the the ClinO-MD comes into force will remain valid, with two additional requirements:

  • The results of the clinical investigation must be published in a primary registry
  • In case of significant changes to a clinical investigation, the sponsor must simultaneously ask for the study to be recategorized according to the new legislation (Art. 6 ClinO-MD)

Details on the changes will be presented in the CTU Lecture on 16th June 2021 (GCP Refresher 4/4) and in the June edition of the CTU Newsletter. Further information can be found on the following websites:

Swissmedic: https://www.swissmedic.ch/swissmedic/en/home/medical-devices/klinische-versuche/bewilligungspraxis-mai-2021.html

Swissethics: https://swissethics.ch/en/news/2021/03/16/klinische-versuche-mit-medizinprodukten-aenderungen-in-den-gesetzlichen-vorgaben-und-basec

Kofam: https://www.kofam.ch/en/applications-and-procedure/klinische-versuche-mit-medizinprodukten-en/

Ordinance text:

ClinO-MD (in German / KlinV-Mep): https://www.fedlex.admin.ch/eli/cc/2020/553/de

ClinO-MD (in French / OClin-Dim): https://www.fedlex.admin.ch/eli/cc/2020/553/fr