MHRA

Please note this is an extract of the original bulletin. Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles Page summary: Guiding principles for the use of Predetermined Change Control Plans (PCCPs) for managing rapid product changes. Change made: First published. MHRA and international partners publish five guiding principles for machine learning-enabled medical devices Page summary: The Medicines…

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: The 'COVID-19 test validation approved products' file has been updated. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: The webinar recording has been…

Please note this is an extract of the original bulletin. The Northern Ireland MHRA Authorised Route (NIMAR)* Page summary: The UK government has introduced the Northern Ireland MHRA Authorised Route (NIMAR). This new route for supply became operational 1 January 2022. Change made: Information added about transitional arrangements for licences associated with the implementation of the Windsor Framework and links…

Please note this is an extract of the original bulletin. The Innovative Devices Access Pathway (IDAP) Page summary: The Innovative Devices Access Pathway (IDAP) program is designed to accelerate the development of cost-effective medical devices and their integration in to the UK market. Change made: First published. Medical devices given exceptional use authorisations during the COVID-19 pandemic Page summary: List…

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:…