Swiss medtech industry has been downgraded to «third country» equivalency. From now on, Swiss companies will have to meet stricter requirements when exporting
their medical devices to the EU. The Swiss medtech industry has worked hard to prepare for this day as best possible.
The new EU Medical Device Regulation (MDR) replaces the existing EU Directives (Medical Device Directive, MDD) and the corresponding Swiss medical device
legislation enters into effect. When the MDR comes into force, the Swiss medical technology industry will lose its existing barrier-free access to the EU single market. The reason: a
prerequisite for the barrier-free trade in goods – namely the updating of the Mutual Recognition Agreement (MRA) – has not been fulfilled to date. The EU had already made it clear in late
2018 that it would neither conclude new bilateral agreements with Switzerland, nor update existing ones, without the Institutional Agreement (InstA) being initialled. This effectively turned
the medtech industry into a tactical «ball» in the political game between the EU and Switzerland.