Following an earlier announcement from the Swiss Federal Council on the revision of the Ordinance on clinical trials with medica devices (ClinO-MD), Swissmedic has recently released practical advice for applicants on the transition to the new regulation.
ClinO-MD will come into force on 26 May 2021 in line with the European Union Medical Device Regulation (EU MDR). Note that ClinO-MD only pertains to devices regulated under the EU MDR and as such does not cover In Vitro diagnostic (IVD) devices.
Initially, the advice covers the transition to submitting trial applications under the new regulation. It is recommended that missing documentation for pending applications be submitted promptly in order to conclude the process prior to the 26 May implementation date of ClinO-MD. For new applications, it is recommended to wait until 01 May before making a submission as this will ensure a decision is granted after the implementation date. From 01 May, new submissions must be made simultaneously to Swissmedic (via the eMessage portal) and to the cantonal ethics committee (via BASEC). New applications must follow the format of the revised forms and extended folder structure which will be introduced under ClinO-MD (the agency will provide more details on this at a later date). Ongoing trials approved under the previous law (ClinO) remain valid, however if they are ongoing, they must be regulated in line with the new law. This primarily concerns the reporting obligations whilst conducting a trial. Furthermore, trials completed after the 26 May implementation date must have their results published in a register in line with the ClinO-MD regulation.
New requirements for investigational devices without CE marking include manufacturers’ declarations, standards lists and device requirement lists. The guidance also covers the new approach to reporting of serious adverse events (SAE) and device deficiencies.
To view the full notice, click here.