Federal Council breaks off negotiations on the institutional agreement with the EU: Consequences for the clinical research of medical devices in Switzerland
On May 26, the Medical Device Regulation (MDR) at EU level and in Switzerland the ordinance for clinical trials of medical devices (ClinO-MD) came into force. At the same time, Switzerland broke off the negotiations on the institutional agreement with the EU. Thus, the necessary political basis for a future mutual recognition of conformity for medical devices and barrier-free access to the EU internal market is no longer given. In addition, the connection of Switzerland to the European portal EUDAMED and thus to the reporting system of the EU has become a distant prospect.
However, the current alignment of the ordinance ClinO-DM to the European regulation will continue to allow sponsors to carry out clinical research in Switzerland in line with the European requirements. The submission portal BASEC has also been programmed in such a way that documents can be uploaded and submitted in compliance with MDR. The coordination between Swissmedic and the ethics committees for the national decision according to ClinO-MD and MDR remains unaffected by the new political decisions.