
Apr 18, 2023
Europe
The article highlights the key points related to the regulatory requirements for performance studies involving in vitro diagnostic medical devices. Table of Contents Swissmedic, a Swiss Agency for Therapeutic Products, has published an information sheet dedicated to...
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Jan 27, 2023
EU MDR/IVDR
The article provides an overview of the FAQ document addressing the key points related to notifications for medical devices. Table of Contents SwissMedic, a country’s regulating authority in the sphere of healthcare products, has published a guidance...
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Jan 24, 2022
Europe
The second article addresses specific matters associated with the use of medical devices in healthcare institutions, including the obligations in the sphere of incident notification or direct import. Table of Contents Swissmedic, the country’s regulatory...
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Jan 13, 2022
switzerland
The first article provides a brief overview of the Swiss legislation in the sphere of medical devices, and also describes in detail the recent changes thereto. Table of Contents Swissmedic, a Switzerland’s regulatory agency in the sphere of healthcare...
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Sep 3, 2021
EU MDR/IVDR
SwissMedic, the Swiss regulating authority in the sphere of medical devices, has published a guidance document dedicated to the obligations of parties involved in operations with medical devices, other than manufacturers: authorized representatives, importers, and...
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May 27, 2021
Europe
The Swiss Federal Office of Public Health, a division of the Federal Department of Home Affairs, has published an explanatory notice describing upcoming changes to the medical devices regulations. Regulatory Background The document provides additional clarifications...
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