MHRA MedTech Regulatory Reform Webinar MHRA's MedTech Regulatory Reform Webinar will take place on Tuesday 5 March 2024 from 10:30am-12:00pm. The webinar will give information about MHRA’s intentions for the future medical device regulations. MHRA MedTech Regulatory Reform Webinar
MHRA Designates Two New Approved Bodies for Medical Devices The Medicines and Healthcare products Regulatory Agency (MHRA) has designated two new UK Approved Bodies. MHRA Designates Two New Approved Bodies for Medical Devices
EU MDR/IVDR Implementation – Post-Market Surveillance and Vigilance: Device Specific Guidance (DSVG) and Template DSVG and a template have been published on the Commission website. EU MDR/IVDR Implementation – Post-Market Surveillance and Vigilance: Device Specific Guidance (DSVG) and Template
EU MDR/IVDR – Legislative Proposal for Certain IVDs Published The Commission has published a legislative proposal for amending the EU MDR and IVDR as regards the gradual roll-out of Eudamed, an information obligation in case of interruption of supply and the transitional provisions for certain in vitro diagnostic medical devices. EU MDR/IVDR – Legislative Proposal for Certain IVDs Published
Border Target Operating Model (BTOM) material The Cabinet Office has published useful material on BTOM. Border Target Operating Model (BTOM) material
MHRA Launches New Fees Calculator MHRA has developed a fees calculator to help companies calculate the fees they will be charged when making an initial or a variation application for a medicinal product. MHRA Launches New Fees Calculator
NHS Standard Contract 2024/25 Consultation NHSE has published the draft 2024/25 NHS Standard Contract for consultation. The consultation paper describes the main, material changes being proposed in the Contracts. NHSE welcome comments from stakeholders and Industry on the proposals. NHS Standard Contract 2024/25 Consultation
Roadmap Towards the Future Regulatory Framework for Medical Devices in the UK Roadmap Towards the Future Regulatory Framework for Medical Devices in the UK MHRA has published the roadmap towards the future... Roadmap Towards the Future Regulatory Framework for Medical Devices in the UK
DHSC Review of the Risk of Modern Slavery in the NHS Supply Chain DHSC Review of the Risk of Modern Slavery in the NHS Supply Chain The Department of Health and Social Care... DHSC Review of the Risk of Modern Slavery in the NHS Supply Chain
Border Target Operating Model (BTOM) Webinars Defra is hosting a series of webinars on BTOM. Border Target Operating Model (BTOM) Webinars
MHRA Board Meetings 2024 MHRA Board Meetings 2024 MHRA has shared the dates of the MHRA Board meetings in 2024. The Board meetings in... MHRA Board Meetings 2024
MHRA’s Executive Consultation (How MHRA Communicate with HCP to Improve Safety Published) Summary and Recommendations Published MHRA’s Executive Consultation (How MHRA Communicate with HCP to Improve Safety Published) Summary and Recommendations Published MHRA has published an ... MHRA’s Executive Consultation (How MHRA Communicate with HCP to Improve Safety Published) Summary and Recommendations Published
