New requirements and changes to authorisation practice as of May 2021

Information from the Federal Office of Public Health regarding the transition from the current to the new rules

Changeover to parallel submissions on 1 May 2021

Please note that as of 1.5.2021 submissions (including any subsequent submissions) must be sent on the same day both to Swissmedic and to the responsible cantonal ethics committee. As of 26.5.2021, Swissmedic will only authorise trials if the ethics committee has granted approval of the same version of the trial documentation.

Information sheet of Swissmedic, new clinical trials regulation

New forms and extended folder structure for submissions as of 1 May 2021

As up to now, applications are still to be submitted to Swissmedic via the eMessage portal and those to the ethics committee via BASEC. The forms and the eDok submission format are being adjusted. By 1.5.2021, Swissmedic expects to publish revised forms and an extended folder structure for submission of the files. From then on, please only use the new forms and the new folder structure.

New requirements regarding investigational devices without CE marking

From 26.5.2021, the requirements set forth in Annex 1 of Regulation (EU) 2017/745 (MDR) will apply to investigational devices. New requirements are being used by industry and hospitals to inform new product developments for some time, and Swissmedic thus already accepts the manufacturers’ declarations, standards lists and device requirement lists based on paragraphs 2.7. and 4.1. of Annex XV of the MDR.

For ongoing authorisation procedures, where authorisation will only take place after 26.5.2021, the missing documentation must be submitted. To avoid subsequent enquiries and delays, Swissmedic recommends that these documents already be submitted now.

Swissmedic is providing examples of the standards list and device requirement list that can be downloaded here.

Serious adverse events (SAE) and device deficiencies – reporting in accordance with MDCG 2020-10

In the European Union, reporting in accordance with MEDDEV 2.7/3 is to be superseded as of 26.5.2021. From this date on, reporting in Switzerland too will be based on a new form.

Please note that the causal relationship “unlikely” in MDCG 2020-10 is no longer used. Such reports must be treated in the same way as those classified as “possibly”.

An overview of safety reporting in Switzerland can be found in swissethics.ch

Submitting modifications in Switzerland

Substantial modifications in Switzerland always lead to a written decision; there are no waiting periods with tacit procedures. You can find examples of substantial modifications on the internet pages of the European commission. You can find additional examples and an overview of submissions in Switzerland in a publication of swissethics und Swissmedic.