Trade relations between the European Union and Switzerland are crucial for both territories. The EU is Switzerland’s man trading partner, while Switzerland is the EU’s fourth largest trading partner, after the United States, China, and the United Kingdom. Remarkably, there are over 100 bilateral agreements between the EU and Switzerland.
Classic de Dijon Principle
The Cassis de Dijon Principle stipulates that Member States should mutually recognise their national regulations. This means that a product compliant in one Member State can be placed on another Member State’s market. In Switzerland, the Federal Act on Technical Barriers to Trade (TBA) and the Ordinance on the Placing on the Market of Products manufactured according to Foreign Technical Regulations (CdDO) make the legal basis for the application of the Cassis de Dijon Principle.
Essentially, since 2010, products that are lawfully marketed in the EU and the EEA can be placed on the Swiss market as well. However, there are some exceptions, such as food, medical devices, and medicines.
Selling cosmetics and medical devices in Switzerland
In March 2024, the European Union and Switzerland opened negotiations to reinforce their relationship. Currently, there is no mutual recognition agreement (MRA) for medical devices between the EU and Switzerland and the country does not apply the Cassis de Dijon Principle to medical devices. Consequently, medical devices and IVDs placed on the Swiss market must be fully compliant with local regulations, including the obligation to appoint a Swiss Authorised Representative and comply with local market surveillance requirements.
On the other hand, Swiss law refers to the EU Cosmetics Regulation concerning substance bans and restrictions, with a few exceptions. Principally, manufacturers can place on Swiss market cosmetics which are compliant with the EU Regulation. Nonetheless, several differences concerning labelling requirements, claims, cosmetovigilance, and ingredients’ restrictions must be taken into account when selling in Switzerland.
For any questions on compliance of medical devices and cosmetics in Europe! Contact us today.
Simona Varrella
Regulatory Intelligence & Innovation
28/10/2024
Reference:
Bundesamt für Lebensmittelsicherheit und Veterinärwesen (2016). Cassis-de-Dijon-Prinzip. Retrieved on 25/10/2024.
European Commission (2024). Access2Markets – Switzerland. Retrieved on 25/10/2024.
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