SWITZERLAND Law and Practice Contributed by: Annemarie Lagger and Amina Chammah, Walder Wyss Ltd
warning of a possible increased risk of a throm - boembolic event, compared to earlier genera - tion contraceptive pills, was only included in the expert information, not in the patient information. In its decision of 9 September 2013 (2C_13/2013), the Federal Supreme Court held that the mal - function of a product is considered a product defect if the product’s value is specifically based on its serviceability (ie, a fire extinguisher). On 18 March 2011 (137 III 226), the Federal Supreme Court decided that a producer was not liable for any defects that were not detectable at the time of the market placement according to the then current state of scientific and techno - logical knowledge (so-called development risks). On 4 October 2010, the Federal Supreme Court found that the compensation of an injured party is to be reduced if that party has failed to care - fully study the product manual before using the product (4A_319/2010). In its decision of 19 June 2010 (4A_255/2010), the Federal Supreme Court had to rule on a prod - uct liability claim relating to a defective window. The Court held that the producer was not liable because the window was manipulated after it had been placed on the market, which was beyond the reasonable expectation of the producer. 3. Recent Policy Changes and Outlook 3.1 Trends in Product Liability and Product Safety Policy Medical Devices Until May 2021, market access for medical devices between the EU and Switzerland was facilitated by the MRA (Agreement between the
Swiss Confederation and the European Commu - nity on mutual recognition in relation to conform - ity assessment). This agreement aims to remove trade barriers between Switzerland and the EU. At that time, an update of the MRA was neces - sary to take into account the application of the EU Medical Device Regulation (MDR) and the corresponding legislation in Switzerland. How - ever, for political reasons, it was not possible to update the chapter in the MRA on medical devices. As a result, since 26 May 2021, medical device providers established in Switzerland have no longer benefitted from the trade facilitations under the MRA. Since 26 May 2022, the same problem has applied to in vitro diagnostics. For medical devices and in vitro diagnostics, the EU has classified Switzerland as a third-party coun - try, which means that previously existing trade facilitations under the MRA are now suspended. To mitigate the negative effects of the end of harmonisation under the MRA, the Swiss gov - ernment adopted various mitigation measures with, eg, unilateral recognition of a medical device bearing an EU conformity assessment. In addition, it continues to align its legislation with developments in the EU to maintain equivalence with EU legislation, eg, Switzerland has adapted its legislation to reflect the updated transitional periods under the MDR. In parallel, the Parliament adopted “Motion 20.3211 – For greater room for manoeuvre in the procurement of medical devices to supply the Swiss population” to allow the authorisation of medical devices approved under regulatory systems other than the EU. At the time of writing, the competent authority is still examining the options for implementing this political motion.
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