covid-19

Please note this is an extract of the original bulletin. 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 exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…

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 Combined review of a CTIMP and Medical Device section and accompanying guidance Combined IMP Device guidance Borderlines…

Please note this is an extract of the original bulletin. MHRA Windsor Framework Page summary: New Guidance in accordance with the Windsor Framework Change made: First published. UK Parallel Import Licences Following Agreement of the Windsor Framework Page summary: On this page we provide information on UK Parallel Licences following the Agreement of the Windsor Framework. Change made: First published.

Please note this is an extract of the original bulletin. Regulation of devices in Northern Ireland Page summary: Information about the EU Regulations and their implementation in Northern Ireland Change made: Updated to reflect the coming into force of The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 and to include information on MDCG guidance on the Health…

Please note this is an extract of the original bulletin. 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 exemption by the MHRA. The list also includes manufacturers whose exemption expired or was cancelled. This information will be listed for 2 months after expiry or…

Please note this is an extract of the original bulletin. New action to tackle ethnic and other biases in medical devices Page summary: Government outlines action to make UK a world leader in tackling ethnic and other biases in medical devices. Change made: First published. MHRA response to Equity in Medical Devices: Independent Review Page summary: The MHRA welcomes the…