Swissmedic Online Information Event: New Regulations on In Vitro Diagnostic Medical Devices

On 5 September Swissmedic announced an online information event for new regulations on in vitro diagnostic medical devices.

The new legal requirements for IVDR entered into force on 26 May 2022, at the same time as the application of the IVDR in the EU. The aim of the new regulations is to improve patient safety through the introduction of stricter conformity assessment procedures and performance studies, which ensure the safety and quality of in vitro diagnostic medical devices. In addition, new requirements apply for monitoring, traceability and transparency following placement on the market.

At the online information event, the topics will cover the new and changed requirements and clarify the specifications in Switzerland. The online event will take place on 3 November 2022 and participation is free of charge.

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