Swiss legislators have authorized adoption of new laws to recognize medical devices and in vitro diagnostic (IVD) devices that have received US Food and Drug Administration (FDA) clearance or approval as well as devices with EU CE marking. In doing so, Switzerland joins many other countries that have expanded medical device regulatory authorizations in order to protect continuity of healthcare for their populations.
According to the Swiss Medical Technology Association (Swiss Medtech), adoption of these new laws will create more leeway in terms of procuring medical devices and IVDs for Swiss patients. Manufacturers, Notified Bodies and healthcare providers have noted increasing challenges as the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR) take effect. Lack of Notified Body capacity to take on new clients as well as stricter regulatory requirements are expected to lead to shortages of devices with valid CE certification…
