Swissmedic organises regular events to give an insight into current issues and challenges from a regulatory perspective. Some 1,600 professionals from Switzerland and abroad took part in the virtual event on the key aspects of the new medical devices regulation on 2 September 2021. The presentations from the information event are available to all interested parties to download in four languages.
Successful Swissmedic online event on 2 September 2021
07.09.2021
Interest in the online event on the new medical devices regulation on 2 September 2021 was considerable, with some 1,600 participants from the fields of medical devices and healthcare attending. The event kicked off with information on the role of Swissmedic, focusing on medical devices and the effects of the lack of update to the MRA. The subsequent presentations covered topics ranging from developments in clinical trials of medical devices to the rights and obligations of economic operators, including registration obligations, requirements for devices on the market and notification and monitoring obligations of all parties involved.
The final two presentations were aimed at hospitals and other healthcare institutions, which must meet significantly higher requirements in terms of ensuring the safety of medical devices and thereby patient safety under the new regulation.
The presentations, which also answer many of the queries sent in advance to Swissmedic, are available to all interested parties:
As a supplement to the legal framework, Swissmedic publishes regularly updated implementation guides and answers to frequently asked questions:
See also
26.05.2021
New regulations applicable to medical devices as of 26 May 2021
Modification of the Medical Devices Ordinance (MedDO) in the context of pending agreements between Switzerland and the EU