Overview of the regulatory requirements for medical devices in Switzerland
£35.00
Stay compliant in Switzerland: gain a clear overview of the country’s current regulatory requirements for medical devices and how they impact market access
English
This article by Daniel Delfosse of Swiss Medtech provides a comprehensive overview of the regulatory framework for medical devices in Switzerland. It focuses on Swiss-specific regulatory elements, following the expiration of the Mutual Recognition Agreement with the European Union (EU) on 26 May 2021, and explores the current legal framework and anticipated revisions. Emphasis is placed on additional Swiss requirements that go beyond EU regulations, and a new pathway intended to permit US Food and Drug Administration-approved or -cleared devices to enter the Swiss market.
Specification: 5 pages plus covers, in English, supplied by email as a PDF.
This article has been published in the August 2025 issue of the Journal of Medical Device Regulation.
