40th Notified Body has been designated under the EU MDR 40th Notified Body has been designated under the EU MDR Turkey based Notified Body ‘Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim... 40th Notified Body has been designated under the EU MDR
MHRA AI-Airlock – New Regulatory Sandbox for AI Developers MHRA AI-Airlock – New Regulatory Sandbox for AI Developers MHRA has announced that it is taking forward its ‘regulatory sandbox’,... MHRA AI-Airlock – New Regulatory Sandbox for AI Developers
Twelfth Notified Body Designated Under EU IVDR Twelfth Notified Body Designated Under EU IVDR Finland-based Notified Body ‘Sertio Oy` has been notified as the 12th Notified Body... Twelfth Notified Body Designated Under EU IVDR
MHRA, FDA and Health Canada Identify Five Guiding Principles for Predetermined Change Control Plans MHRA, FDA and Health Canada Identify Five Guiding Principles for Predetermined Change Control Plans The Medicines and Healthcare products Regulatory... MHRA, FDA and Health Canada Identify Five Guiding Principles for Predetermined Change Control Plans
Assignment of UDI for Contact Lenses – Delegated Regulation Published Assignment of UDI for Contact Lenses – Delegated Regulation Published The delegated regulation amending the EU MDR as regards the... Assignment of UDI for Contact Lenses – Delegated Regulation Published
MDCG 2023-4 Medical Device Software Hardware Combinations Guidance Published MDCG 2023-4 Medical Device Software Hardware Combinations Guidance Published The Commission has published a new document: MDCG 2023-4... MDCG 2023-4 Medical Device Software Hardware Combinations Guidance Published
EUDAMED Vigilance Working Group Meeting on 19 October 2023 EUDAMED Vigilance Working Group Meeting on 19 October 2023 The next MDCG EUDAMED Vigilance WG Meeting is taking place on... EUDAMED Vigilance Working Group Meeting on 19 October 2023
24th IMDRF Session 24th IMDRF Session The 24th International Medical Device Regulators Forum (IMDRF) session took place in Berlin, Germany during the last... 24th IMDRF Session
UKNI Mark and CE Mark Guidance Pages Updated UKNI Mark and CE Mark Guidance Pages Updated MHRA has updated the ‘Using the UKNI marking‘ and... UKNI Mark and CE Mark Guidance Pages Updated
MHRA Board Meeting Recording – 19 September 2023 MHRA Board Meeting Recording – 19 September 2023 The recording and board meeting pack of the MHRA Board Meeting... MHRA Board Meeting Recording – 19 September 2023
DHSC IDAP Webinar DHSC IDAP Webinar The Innovative Devices Access Pathway (IDAP) pilot, a program designed to accelerate the development of cost-effective medical... DHSC IDAP Webinar
EU MDR Implementation – Q&A Document on Transitional Provisions for Annex XVI Products Published EU MDR Implementation – Q&A Document on Transitional Provisions for Annex XVI Products Published The Commission has published the Q&A... EU MDR Implementation – Q&A Document on Transitional Provisions for Annex XVI Products Published
