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...
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...
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...
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...
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...
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...
