EU MDR/IVDR The European Commission (EC), the EU body responsible for medical device regulations, has published a Q&A document dedicated to in vitro diagnostic medical device conformity assessment and performance in the context of COVID-19. The guidance is intended to provide...
FDA The Food and Drug Administration (FDA), the US regulating authority in the sphere of medical devices, has published a transcript of the virtual town hall dedicated to the guidance on Coronavirus (COVID-19) diagnostic tests issued earlier by the Agency. The conference...
COVID-19 The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, has issued a final version of the guidance dedicated to the multiple function device products. Regulatory Background The regulatory framework to be applied for a...
COVID-19 The Food and Drug Administration (FDA) has published a new template for emergency at-home and over-the-counter diagnostic COVID-19 tests and medical devices for use in non-lab settings, such as homes, offices, or schools. FDA: Regulatory Background In order to...
Australia and Oceania The Therapeutic Goods Administration (TGA), the Australian authority responsible for medical devices regulation, issued guidelines describing how medical device manufacturers shall apply for inclusion of the COVID-19 test in the national register of medicinal products...
