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...
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...
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...
Europe Swissmedic, the Swiss agency for therapeutic products, announced the implementation of a new technical standard to be used when submitting a marketing authorization application for a medicinal product. The present document constitutes an improved version of the...
