MHRA

Please note this is an extract of the original bulletin. Yellow Card centre launched in Northern Ireland to strengthen patient safety Page summary: A new regional centre to promote Yellow Card reporting has been launched in Belfast today. Change made: First published.

Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Published updated ‘COVID-19 test validation approved products’ MHRA Corporate Plan 2023 to 2026 Page summary: This plan outlines the agency’s strategic direction over the next three years. Change made: This page now…

Please note this is an extract of the original bulletin. Three new UK Approved Bodies to certify medical devices announced by the MHRA Page summary: The Medicines and Healthcare products Regulatory Agency (MHRA) has designated three new UK Approved Bodies, almost doubling the UK’s capacity to certify medical devices, supporting faster certification of safe and effective medical devices for healthcare…

Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: COVID-19 test validation approved products spreadsheet updated. Medical devices: UK approved bodies Page summary: UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002). Change made:…

Please note this is an extract of the original bulletin. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have been approved. Change made: Published updated ‘COVID-19 test validation approved products’ data. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List of manufacturers and their medical devices which have been granted an…

Please note this is an extract of the original bulletin. How tests and testing kits for coronavirus (COVID-19) work Page summary: The different types of tests and testing kits for COVID-19, and the specifications for manufacturers. Change made: The guidance on performing variant analysis for manufacturers of SARS-CoV-2 screening and diagnostic assays has been updated. Updated guidance documents are included…

Please note this is an extract of the original bulletin. CE marking recognition for medical devices and in vitro diagnostics Page summary: The Medicines and Healthcare Regulatory Agency (MHRA) has released a statement on CE marking recognition for medical devices and in vitro diagnostics. Change made: First published. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers…

Please note this is an extract of the original bulletin. Medical devices: guidance for manufacturers on vigilance Page summary: Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA. Change made: Guidance updated to reflect the latest information regarding the MORE portal. COVID-19 test validation approved products Page summary: Find out which…