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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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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Aug 8, 2020
Europe
Swissmedic, a Swiss authority responsible for medical device regulations, has published an information sheet dedicated to the marketing authorization of non-conforming medical devices. In particular, the document describes the rules and procedures to be applied for...
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