MHRA AI Airlock Launched MHRA has launched AI Airlock, a regulatory sandbox for AI as a Medical Device (AIaMD) to address challenges for regulating devices using AI. MHRA AI Airlock Launched
47th Notified Body Designated Under the EU MDR Italy-based Notified Body ‘MTIC InterCert S.r.l.’ has been notified as the 47th Notified Body under the MDR. 47th Notified Body Designated Under the EU MDR
MHRA AI Strategy Paper Published MHRA has published its strategic approach to AI, setting out how MHRA approaches AI as a regulator of AI products. MHRA AI Strategy Paper Published
Notify MHRA About a Clinical Investigation for a Medical Device – Guidance for Manufacturers Updated MHRA has updated the guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices to update the guidance for manufacturers. Notify MHRA About a Clinical Investigation for a Medical Device – Guidance for Manufacturers Updated
EUDAMED Information Centre Survey The Commission has added a new tab on the EUDAMED Playground Information Centre landing page: ‘Give us your feedback’, as part of work to improve the EUDAMED Information Centre. EUDAMED Information Centre Survey
Notify the MHRA About a Clinical Investigation for a Medical Device – Guidance Updated MHRA has updated their guidance on how to notify the MHRA of your intention to carry out a clinical investigation for medical devices Notify the MHRA About a Clinical Investigation for a Medical Device – Guidance Updated
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
