EU MDR/IVDR The Compliance and Enforcement Group (COEN), an EU body focused on the sphere of information exchange between market surveillance authorities and coordination of enforcement activities, has issued a checklist dedicated to the instructions for use (IFU) for reusable...
Asia The Ministry of Food and Drug Safety (MFDS), the South Korean authority responsible for medical devices regulation, published a brochure providing an overview of the existing regulatory framework. The document covers the most important aspects related to medical...
FDA The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices regulation, issued an enforcement policy dedicated to the telethermographic systems in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused...
FDA The Food and Drug Administration (FDA) issued guidance dedicated to the digital health devices used to treat psychiatric disorders in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus” and...
COVID-19 The European Commission (EC), the European authority responsible for medical devices regulation, issued guidance dedicated to medical devices, active implantable medical devices, and in vitro diagnostic medical devices in the context of Coronavirus Disease 2019...
