On Sunday September 27, 2020, a referendum was held in Switzerland, which keeps the door open for a Mutual Recognition Agreement (MRA) between Switzerland and the EU concerning medical devices.
The initiative called for a restriction on the free movement of persons between the EU and Switzerland. A clear majority voted against it. The free movement of persons is one of the pillars of the EU, alongside the free movement of goods. A vote against it would have promoted the Swixit process.
However, the MRA has not yet been fully implemented for medical devices covered by the MDR/IVDR. The Commission made it clear that, at the time of the MDR due date in May 2021, the existing MDD agreement would no longer apply to the MDR. In addition, it was also clarified that the additional transitional period does not apply to MDD-certified products either.
- Manufacturers in Switzerland need an EC REP if they want to place products on the EU market.
- Manufacturers in the EU who market their products in Switzerland then need an authorized representative in Switzerland.
For our EC REP clients:
- The representative in the EU will not be accepted in Switzerland. Manufacturers outside the EU (Switzerland) will then need an authorized representative in Switzerland (similar to the UK REP in the UK).
This clear result of this referendum seems to be moving in the right direction, and a solid MRA is more likely now.
MDSS will monitor the development closely.