The information event about the revised Medical Devices Ordinance, scheduled for 4 May 2020, has been cancelled.
The reasons for this are:
In May 2020, the new regulations on medical devices will take effect in the EU and in Switzerland. A key element of this is a European database (EUDAMED). In late 2019, the European Commission announced that this database would not be made available until May 2022, rather than May 2020 as planned. The contracting states and European bodies are currently working to clarify what impact this will have on the implementation of the new regulations.
In parallel, due to political circumstances – in particular the pending update of the Medical Devices section of the Mutual Recognition Agreement (MRA) – a number of open issues will not be resolved before the end of May 2020.
Consequently, it will not be possible at this point to hold an information event on 4 May 2020 as planned that will meet the expectations of participants. Although all involved are working on finding solutions to pending EU-related issues and their consequences for Switzerland, reliable information concerning the implementation will not be published until a later date. Information regarding political developments can be found on the websites of the SECO as well as that of the European Commission.
The new date for the information event about the revised Medical Devices Ordinance for healthcare professionals will be published here in due course.
Please address any questions to Swissmedic via the usual channels: