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...
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...
MHRA
The Medicines and Healthcare products Regulatory Agency (MHRA), UK’s authority responsible for the regulation of medical devices, issued guidance on field safety notices (FSNs). The document is intended to assist medical device manufacturers in preparing the...
