This Newsletter discusses the revision of the Swiss Medical Devices Ordinance (effective as of 26 May 2021). The revised regulations both in Switzerland and the EU impose increased responsibilities on MedTech companies. The delay in renewing the mutual recognition agreement between Switzerland and the EU forced the Swiss Federal Council to enact last-minute amendments and mitigation measures.
Lorenza Ferrari Hofer, Philipp Groz, Sarah Leins-Zurmuehle
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