Theme Artificial intelligence Target Audience Manufacturers, notified bodies, competent authorities Products concerned MD and IVD integrating artificial intelligence systems (AIS) In June 2025, the MDCG published a guide concerning the interconnection between the MD...
Publications : Qualification
UE – MDCG 2025-5 Questions & Answers regarding performance studies of in vitro diagnostic medical devices under regulation (EU) 2017/746 – june 2025
Theme Performance studies Target Audience Sponsors of performance studies, manufacturers Products concerned IVD The MDCG published a question and answers document in June 2025 regarding performance studies of in vitro diagnostic (IVD) medical devices conducted under...
UE – MDCG 2025-4 : Guidance on the safe making available of medical device software (MDSW) apps on online platforms – june 2025
Theme Making available medical device software applications on the market Target Audience Suppliers of medical device software application platforms Products concerned MD and IVD software applications In June 2025, the MDCG published a guide describing the roles and...
Documentary Synthesis Artificial Intelligence
Area Publication or last update date Source organization Text Applied to the DM sector Key words Int 2025 IMDRF Good Machine Learning Practice for Medical Device Development: Guiding Principles x AI, developpment Int 2024 IMDRF Good machine learning practice for...
Virginie Collar EN
Graduated from an engineering school in Biomedical Sciences, I have always been interested in technological advancements serving healthcare. I then chose to specialize in clinical research to be more closely involved in the benefits brought to patients. I worked as a...
Summaries of MDCG documents
This table lists all the documents published by the Medical Devices Coordination Group (MDCG), and helps to know at a glance the theme, the target audience and the type of MD concerned for each document. Would you like to know more? Find the complete summary of each...
UE – MDCG 2025-3 – EMDN Version History – jan 2025
Theme EMDN Target Audience Manufacturer, competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published an excel table showing the revision history of all EMDN codes added, deleted or modified in 2024.
UE – MDCG 2025-2 – Summary of EMDN 2024 Submissions and outcome of annual revision – jan 2025
Theme EMDN Target Audience Manufacturer, competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published a document presenting the results of the analysis of submissions made during the annual procedure for revising the European...
UE – MDCG 2025-1 – EMDN Ad hoc procedure – jan 2025
Theme EMDN Target Audience Competent authorities, notified bodies Products concerned MD, IVD In January 2025, the MDCG published a model form for submitting proposals under the ad hoc updating procedure for the European Medical Device Nomenclature (EMDN). As a...
Liability for defective product Directive (EU) 2024/2853: what’s new for MD and IVD manufacturers?
On the eve of its 40th anniversary, the Liability for defective product Directive is being renewed to adapt to technological innovations, combat legal inconsistencies and ensure legislative consistency within the EU. Published in the Official Journal of the European...