On 18 March 2024, Swiss President Viola Amherd and European Commission President Ursula von der Leyen have opened negotiations to strengthen and expand the relationships between Switzerland and the European Union. Following the exploratory discussions over the past years and the adoption of the negotiating mandates in March, Switzerland and the Commission have started the negotiations on their bilateral relations’ package, which could be concluded already by end of 2024.
What the bilateral relations foresee
In light of the shared economic, cultural, and social values – outlined also in the Common Understanding published in 2023 – both sides agree on the importance of maintaining a strong cooperation. Some of the key elements of the package under negotiations include:
- Barrier-free access to the market through an alignment with EU law
- Negotiations on sectorial agreements on electricity, food safety, and health
- Switzerland’s participation in EU programmes
Among other measures, the EU is aiming at ensuring protection of all EU citizens’ rights working in Switzerland, independently from the Member State they come from.
Impact on markets and manufacturers
The mandates allow for negotiations of bilateral agreements which could result in a Mutual Recognition Agreement (MRA) between the two areas. The actual impact these ongoing negotiations will have on the placing on the market of medical devices or other products is still to be clarified.
Currently, Switzerland applies the Cassis de Dijon principle. According to this principle, products that are EU compliant can be placed on the Swiss market as well. However, this does not apply to products mentioned in the negative list of the Cassis de Dijon principle. Some EU-compliant products which can enter the Swiss market without further controls are cosmetics, toys, textiles, and some food products (with certain restrictions). Medical devices and IVDs are not covered by the Cassis de Dijon principle.
According to the current regulatory status, all non-Swiss manufacturers of medical devices and IVDs (except when based in Lichtenstein) that want to place their medical devices on the market need an CH-REP, an authorised representative based in Switzerland.
Simona Varrella
Regulatory Intelligence & Innovation
20/03/2024
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Reference:
European Commission (2024) The European Union and Switzerland launch negotiations to deepen bilateral relations. Retrieved on 20/03/2024.
Swissmedic (2024) President Amherd and European Commission president Ursula von der Leyen open negotiations between Switzerland and the EU. Retrieved on 20/03/2024.
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