41st Notified Body has been designated under the EU MDR 41st Notified Body has been designated under the EU MDR Turkey based notified body ‘UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi... 41st Notified Body has been designated under the EU MDR
Government Published a Collection of Import Risk Categories for Live Animals, Animal Products, Plants and Plant Products imported to Great Britain Government Published a Collection of Import Risk Categories for Live Animals, Animal Products, Plants and Plant Products imported to Great... Government Published a Collection of Import Risk Categories for Live Animals, Animal Products, Plants and Plant Products imported to Great Britain
MedTech Europe – Future Regulatory Frameworks of the EU MDR/IVDR Position Paper Published MedTech Europe – Future Regulatory Frameworks of the EU MDR/IVDR Position Paper Published MedTech Europe has published its position paper... MedTech Europe – Future Regulatory Frameworks of the EU MDR/IVDR Position Paper Published
Defra Guidance Updated – Export or Move Food, Drink and Agricultural Products Defra Guidance Updated – Export or Move Food, Drink and Agricultural Products The Department for Environment, Food & Rural Affairs... Defra Guidance Updated – Export or Move Food, Drink and Agricultural Products
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