46th Notified Body Designated Under EU MDR French-based Notified Body ‘AFNOR Certification’ has been notified as the 46th Notified Body under the EU MDR. 46th Notified Body Designated Under EU MDR
MDCG Guidance Content of the Investigator’s Brochure (IB) for Clinical Investigations of Medical Devices Published The MDCG has endorsed the guidance document on the content of the investigator's brochure (IB) for clinical investigations of medical devices (MDCG 2024-5). MDCG Guidance Content of the Investigator’s Brochure (IB) for Clinical Investigations of Medical Devices Published
MHRA Newsletter April 2024 MHRA has published the April edition of MHRA News, the monthly newsletter for industry. MHRA Newsletter April 2024
AESGP White Paper Published – Future Regulatory Framework of the EU MDR The AESGP White Paper in relation to the future regulatory framework of medical devices, ‘Lessons learned with the MDR Implementation’, has been published. AESGP White Paper Published – Future Regulatory Framework of the EU MDR
MHRA RegulatoryConnect Webinar Recording Published MHRA has shared a recording of the RegulatoryConnect webinar, giving an overview and demonstration of the new RegulatoryConnect. MHRA RegulatoryConnect Webinar Recording Published
DHSC ‘MedTech Strategy: One Year On’ and ‘MedTech Innovation Classification Framework’ and Webinar DHSC Publishes 'MedTech Strategy: One Year On' and 'MedTech Innovation Classification Framework' detailing the past and future of innovation. DHSC ‘MedTech Strategy: One Year On’ and ‘MedTech Innovation Classification Framework’ and Webinar
Borderlines with Medical Devices and Other Products in Great Britain Guidance MHRA has made minor updates to the Borderlines with Medical Devices and Other Products in Great Britain guidance. Borderlines with Medical Devices and Other Products in Great Britain Guidance
45th Notified Body Designated Under EU MDR Denmark-based Notified Body ‘TÜV SÜD Danmark’ has been notified as the 45th Notified Body under the EU MDR. 45th Notified Body Designated Under EU MDR
Upcoming Stakeholder Workshop: EY Study on Medical Device Regulatory Governance and Innovation EY stakeholder workshop on medical device regulatory governance. Register by April 19 for in-person participation. Upcoming Stakeholder Workshop: EY Study on Medical Device Regulatory Governance and Innovation
MHRA MedTech Regulatory Reform Webinar Recording Watch the MHRA MedTech Regulatory Reform Webinar, providing key updates for the future medical device framework. MHRA MedTech Regulatory Reform Webinar Recording
Commission Releases Annual Overview of Medical Device Consultation Procedures Commission's annual overview of medical device consultation procedures per MDR Article 54(4). Commission Releases Annual Overview of Medical Device Consultation Procedures
MHRA Newsletter Published – March 2024 The MHRA has published the latest edition of its industry newsletter. MHRA Newsletter Published – March 2024
