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...
MHRA The Medicines and Healthcare products Regulatory Agency (MHRA) of the UK has published an update on the way the safety-critical alerts for medicines and medical devices will be issued. The document describes the procedures related to the National Patient Safety...
EU MDR/IVDR The Medicines and Healthcare products Regulatory Agency (MHRA) has published detailed guidance dedicated to the new regulations that will take effect from January 1, 2021. Starting from the aforementioned date, the authority would be fully responsible for all...
Europe The Medical and Healthcare products Regulating Authority (MHRA) has published a response to the report of the Independent medicines and medical devices safety (IMMDS) review. Report on Safety Review in Brief The review is based on the principle stating that the...
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....
Europe The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) issued guidance on 3D printing of medical devices and components in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19). Scope of the MHRA Guidance The present guidance published by...
