More 10 posts of Daniel Donauer

Swiss database for medical devices (swissdamed) from Swissmedic

Switzerland has comprehensively revised its regulation for medical devices and in vitro diagnostic medical devices in order to improve safety and quality and to align with EU regulations. Due to the failure to update the Mutual Recognition Agreement (MRA), Switzerland has been considered a third country in the area of medical devices since May 2021 and in the area of in vitro diagnostic medical d…

Case law of the Swiss Federal Supreme Court: Product regulatory classification of CBD oils

The conceptual distinction between foodstuffs and cosmetic products is extremely important from a legal perspective (e.g. with regard to the legality of a product) and, as a result, is regularly addressed in practice, for example recently in the Federal Supreme Court decision 2C_576/2023 of January 18, 2024. In this decision, the Federal Supreme Court had to evaluate – in the sense of an obiter d…

European Reforms and Swiss Medtech: New Legislative Amendment on 1 November 2023 About Medical Devices That Have Non-medical Purpose

More than two years have passed after the breakdown of negotiations between Switzerland and the European Union (hereinafter: EU), followed by the set of new European regulations with the primary objective of enhancing the safety standards for medical devices. Switzerland has had to constantly adapt its legislation in this area to align with the heightened standards imposed by the EU.

Regulatorische-Rahmenbedingungen-E-Zigaretten-Vapes

Swiss Regulatory Framework for the Sale of E-Cigarettes (Vapes) Today and Under the New Tobacco Products Act as of 2024

Due to numerous new forms of consumption, the tobacco market has changed in recent years. New products such as electronic cigarettes (e-cigarettes), disposable vapes and other nicotine-containing products for oral use are now available to consumers as alternatives to conventional (nicotine-containing) cigarettes and are one of the reasons why the number of cigarette packs sold in Switzerland is d…


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