EU MDR

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: Reference guides and the videos ‘update devices and update products individually’ and ‘review and…

Please note this is an extract of the original bulletin. Human medicines: register of electronic export certificates Page summary: Department of Health and Social Care and MHRA register of electronic export certificates (human). Change made: Added Register of Electronic Export Certificates Issued by the MHRA (Human) – May 2023 PDF and XLS files Notify the MHRA about a clinical investigation…

Please note this is an extract of the original bulletin. COVID-19 test approval: how to apply Page summary: How test manufacturers or distributors can apply for approval of their tests to sell on the UK market. Change made: Updated notice on change to the application process. Global AI challenge to investigate veterans’ cardiovascular health launched Page summary: A brand-new challenge…

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: Reference guides updated and new video tutorials added. MHRA fees Page summary: Fees payable…

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: Changes to DORS instructions for Scenarios 1 to 4 in the Guidance on registration…