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...
EU MDR/IVDR
The European Commission (EC), the medical device regulating authority of the European Union, issued a new regulation regarding standardization aspects in the context of Medical Devices Regulation 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation...
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...
COVID-19
The Medicines and Healthcare products Regulatory Agency (MHRA) announced a set of measures taken to address hazards caused by the outbreak of Coronavirus Disease 2019 (COVID-19) caused by the virus “SARS-CoV-2” or the “novel coronavirus.” These...
Europe
MHRA Guidance on Medicines and Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA), the UK authority responsible for medical devices regulation, published updated guidance on distinguishing medicines and medical devices in controversial...
