Swissmedic organises regular events to give an insight into current issues and challenges from a regulatory perspective. Some 700 professionals from Switzerland and abroad took part in the virtual event on the key aspects of the new in vitro diagnostic medical devices regulation on 3 November 2022. The presentations from the information event are available to all interested parties to download in four languages.
More than 700 participants at the information event on the new in vitro diagnostic medical devices regulation
Successful Swissmedic online event on 3 November 2022
10.11.2022
Interest was considerable: Some 700 participants from the diagnostics industry, medical laboratories and the healthcare sector attended the online event on the new in vitro diagnostic medical devices regulation on 3 November 2022. 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 Mutual Recognition Agreement (MRA) with the EU. The subsequent presentations covered topics ranging from innovations in performance studies with IVDs to the vigilance obligations of all stakeholders and the requirements and obligations of healthcare institutions regarding in-house IVDs.
The rights and obligations of economic operators, requirements for devices on the market and registration obligations were also covered.
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
26.05.2022
New regulations applicable to in vitro diagnostic medical devices as of 26 May 2022
Entry into force of the new Ordinance on In vitro Diagnostic Medical Devices (IvDO) and amendment of the Ordinance on Clinical Trials with Medical Devices (CTO-MedD)