CE marking

Please note this is an extract of the original bulletin. 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: The three PDFs for BSI Assurance UK Ltd have been updated. COVID-19 test validation approved products Page summary: Find out which COVID-19 test products have…

Please note this is an extract of the original bulletin. Notify the MHRA about a clinical investigation for a medical device Page summary: How to notify the MHRA of your intention to carry out a clinical investigation for medical devices. Change made: Added template for submitting Quarterly Summary Reports. Medical devices: UK approved bodies Page summary: UK approved bodies listed…

Please note this is an extract of the original bulletin. Implementation of medical devices future regime Page summary: The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices. Change made: Added ‘Roadmap for the Implementation of the Future Regulatory Framework for Medical Devices’ and information about ‘future core regulations’. Regulatory…

Please note this is an extract of the original bulletin. MHRA’s new International Recognition Procedure (IRP) goes live from 1 January 2024* Page summary: In partnership with other global regulators, IRP is expected to further help bring life-saving new medicines to UK patients. Change made: First published. *Please note this update does not include medical and IVD devices. Unfettered Access…

Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added recording of ‘MHRA International Recognition Webinar November 2023’. *Please note this update does not include medical and IVD devices. Notify the MHRA about a clinical investigation for a medical device Page summary:…

The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK. Subscribe to their new monthly newsletter to stay informed on what is going on at the MHRA. MHRA Newsletter December 2023 Please note this is an extract of the original bulletin. Clinical Trials and Investigations Performance The latest MHRA performance data shows…

Please note this is an extract of the original bulletin. Consultation on how MHRA communicate with healthcare professionals to improve medicines and medical devices’ safety Page summary: The MHRA is reviewing its approach to engagement with healthcare professionals to improve the safety of medicines and medical devices. Change made: Published Executive summary of consultation and recommendations. COVID-19 test validation approved…

Please note this is an extract of the original bulletin. Register medical devices to place on the market Page summary: How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland Change made: Clarification concerning fees and actions required to change legislation of a registered device. The…

Please note this is an extract of the original bulletin. International Recognition Procedure* Page summary: How to use this new procedure for medicines licensing applications. Change made: Added guidance on the Eligibility Checker and submitting your Marketing Authorisation application, IRP Product Lifecycle & eCTD guidance for MAs and Lifecycle. MHRA fees* Page summary: Fees payable to the MHRA for 2023…

Please note this is an extract of the original bulletin. MHRA authorises world-first gene therapy that aims to cure sickle-cell disease and transfusion-dependent β-thalassemia Page summary: Casgevy (exagamglogene autotemcel) is based on the innovative gene-editing tool CRISPR, which won its inventors the Nobel Prize in 2020 Change made: First published.