On 26 May 2021, as a result of the lack of compromise on some crucial points of the draft agreement, the Swiss authorities decided not to sign the institutional agreement with the European Union. Thus, the negotiations between the European Union and Switzerland ended in failure and the institutional agreement aimed at secured Switzerland’s barrier-free access to the EU internal market and enabling its expansion was not signed.
The European Union has repeatedly emphasized that signing of the institutional agreement is a condition for the conclusion of new agreements regarding Swiss access to the internal market. Thus, the update of the Mutual Recognition Agreement (MRA) for medical devices is in question. What does this mean? Failure to update the Mutual Recognition Agreement will result in significant restrictions on the export of Swiss medical devices to the European Union. In this regard, Switzerland will have the status of a third country which -in order to sell medical devices on the EU internal market- will have to meet strict EU requirements – among other things, the Medical Devices Regulation, which apply since 26 May 2021. Switzerland will therefore lose its previous unrestricted access to the EU market.
The Swiss medical technology industry therefore faces a considerable challenge to adapt to the new political and economic reality.
One of the solutions aimed at facilitating access of Swiss companies to the internal market could be the establishment of a subsidiary in the European Union, whose task would be to represent the company on the internal market, obtain any administrative permits and meet the requirements of European Union law, as well as the further sale of goods on the internal market. The establishment of a company in an EU country would solve at least part of the problems that have arisen due to the lack of an update of the MRA and would allow to overcome the difficult situation currently faced by Swiss medical technology companies.
Katarzyna Kowalewska-Glegoła, LL.M., attorney at law (PL)