news & publications

UE – MDCG 2025-6 : Interplay between the Medical Devices Regulation (MDR) & In vitro Diagnostic Medical Devices Regulation (IVDR) and the Artificial Intelligence Act (AIA) – june 2025

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...

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...

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...

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