EU MDR/IVDR
The new article provides an overview of the medical device classification rules adopted in the European Union and highlights the key points associated thereto. Table of Contents The Borderline and Classification Working Group (BCWG), a subgroup of the Medical Device...
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 or the Agency), the US regulating authority in the sphere of medical devices and other healthcare products, has published a guidance document dedicated to the policy for evaluating the impact of viral mutations on COVID-19 tests....
MHRA
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published the Target product profile (TPP) for the tests intended for the point of care use to detect the virus SARS-CoV-2 (the “novel...
COVID-19
The Food and Drug Administration (FDA) issued updated guidance dedicated to tests intended to be used in the context of the outbreak of COVID-19. Due to the importance of the highlighted issues, the guidance is subject to immediate implementation without public...
