MHRA
The Medicines & Healthcare products Regulatory Agency (MHRA), the UK regulating authority in the sphere of medical devices, has published detailed guidance dedicated to the off-label use of medical devices. The scope of the guidance covers only the medical devices...
Australia and Oceania
The Therapeutic Goods Administration (TGA) of Australia has published detailed guidelines dedicated to the regulation of Personal Protective Equipment (PPE) in the context of the outbreak of COVID-19. These devices are facing a significant increase in demand during...
EU MDR/IVDR
The Medical Device Coordination Group (MDCG) has published a Q&A dedicated to conformity assessment procedures for protective equipment. The document has been developed to provide the manufacturers and other parties involved with additional information to achieve...
COVID-19
The Medicines and Healthcare products Regulating Authority (MHRA), the UK authority in the sphere responsible for medical devices, issued guidance dedicated to medical devices and personal protective equipment intended to be used in the context of COVID-19....
COVID-19
The Food and Drug Administration (FDA) issued guidance to provide recommendations for industry representatives applying for the Emergency Use Authorization (EUA) for decontamination and bioburden reduction systems. The document describes special extraordinary measures...
