Regulatory Challenges and Implications of UK and Switzerland Leaving the EU

First Brexit, now Swissxit, what’s next? Even since the initial Brexit announcement in 2017, the UK has been preparing for new regulations to govern market access to medical devices for its population. Fast forward 5 years, we are still awaiting the details of how this will be conducted.

In the meantime, Switzerland, a non-EU country that has previously negotiated many sectoral agreement with the EU, including access to market, was unable to re-negotiate a mutual agreement and has therefore been forced to release their own regulations. In July 2020, the Swiss authorities released their own ordinance on Medical Devices and many more details on the execution are still forthcoming.

This session will provide an overview of the regulatory challenges the Medical Device and IVD Industry faces in light of UK and now Switzerland exiting the EU.