news & publications

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...

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...

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