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Tiziana Hongler

Tiziana Hongler is an Associate in Baker McKenzie, Zurich office.

On 29 March 2023, the Swiss Federal Council, the executive body of Switzerland, announced its decision to implement an extension of the transitional periods for the certification of medical devices under the Swiss Medical Device Ordinance (“MedDO”) and the Ordinance on In Vitro Diagnostic Medical Devices (“IvDO”), in line with the amendment of transitional provisions in the European Union under Regulation (EU) 2023/607.
The implementation of these amended transitional provisions requires the formal amendment of the MedDO and the IvDO. These amendments are expected to be adopted in autumn 2023.

In its decision of 12 September 2022, the Swiss Federal Administrative Court confirmed that interpretive software that uses indicators such as calendar days and body temperature to monitor fertile and infertile phases of a menstrual cycle to achieve natural conception or prevent undesired pregnancy, qualifies as a medical device. This means that such software is subject to a conformity certification procedure with a notified body.

On 1 December 2022, Switzerland’s new Human Genetic Testing Act will enter into force.
The new HGTA provides a comprehensive legal framework for all types of genetic testing (including direct-to-consumer genetic testing and lifestyle genetic testing) and implements stronger measures to protect privacy rights, prevent abuse of genetic data and ensure the quality of genetic tests and the interpretation of the results.
As part of the comprehensive revision of the HGTA, the Human Genetic Testing Ordinance and the Ordinance on the creation of DNA profiles for civil and administrative purposes have been amended accordingly.

On 1 August 2022, Swiss National Day, Switzerland’s revised Narcotics Act entered into force. The revision aims at facilitating medical treatments and improving research and development of cannabis. Prior to the revised law, patients and physicians had to apply for special authorization from the Federal Office of Public Health if they wanted to access cannabis for medical purposes. The amendment will allow numerous patients safe and timely access to cannabis medicines as part of their treatment regime. This signifies a further step in modernizing Switzerland’s legislation on cannabis.

On 25 May 2022, the Federal Council passed an amendment to the Price Disclosure Ordinance. The purpose of the amendment is to ensure clarity and comparability of prices and to prevent the use of misleading prices. This latest amendment was precipitated by federal court ruling 4A_235/2020, which caused uncertainty on the question of the timing of price disclosure in online trade.