Clinical trials with medical devices: new authorisation practice as of May 2021

2. April 2021 – The legal framework for clinical trials with medical devices is changing. The following new regulations will apply from May 2021:

i) In future, applications and subsequent applications for clinical trials involving medical devices must be submitted to both Swissmedic and the competent cantonal ethics committee on the same day. ii) The forms and the eDok format will be adapted. Swissmedic is expected to publish the information on this on 1 May 2021. iii) From 26 May 2021, the requirements in accordance with Annex I of Regulation (EU) 2017/745 (MDR) will apply to investigational medicinal products.

For more information, see here.