Switzerland’s Parliament Moves to Accept FDA approved Medical Devices
On the 28 Nov 2022, Switzerland’s Parliament took a decision to instruct the Federal Council to incorporate the acceptance of medical devices approved by the United States (US) Food and Drug Administration (FDA) into national law.
In recent months Switzerland has been a hot bed of medical device regulatory news, due to the expiry of their Mutual Recognition Agreement (MRA) with the European Union (EU). During this time Switzerland has been in a phase of change and implementation through amendments of national legislation (SR 812.213 Medical Device Ordinance and SR 812.219 IVD Ordinance) to ensure a regulatory framework is in place to support the supply of medical devices and IVDs to the Swiss population.
Until now an EU CE mark was the route to market but now Switzerland will start to implement a regulatory framework to enable manufactures to place US FDA approved devices on the market. This decision was made to urgently move to ensure and promote the continual supply of medical devices and IVDs, due to the elongated implementation of the MDR and IVDR in the EU and the recent trend of manufacturers switching to the US as an early market entry strategy.
Now Switzerland will move to implement this decision. We will see how this happens in the coming months, but all stakeholders are hoping for an efficient and non-bureaucratic solution.
Director of Consulting Services