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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 2026-3 – 2026 EMDN Version History – april 2026

Theme EMDN  Target Audience Manufacturers, competent authorities, NB  Products concerned MD, IVD  This guide is a log of the changes made during the 2025 annual revision of the EMDN (transition from v.2025 to v.2026). It lists only the codes that have changed,...

UE – MDCG 2026-2 – 2025-2026 Annual Revision Change Log – April 2026

Theme EMDN  Target Audience Manufacturers, competent authorities, NB  Products concerned MD, IVD  This guide presents the complete EMDN nomenclature in version 2026. This file contains all active and inactive EMDN codes, along with their history. It includes:  The...

UE – MDCG 2026-1 – Summary of EMDN 2025 Submissions and outcome of annual revision – april 2026

Theme EMDN  Target Audience Manufacturers, competent authorities, NB  Products concerned MD, IVD  This guide presents the results of the analysis of submissions made during the annual review of the European EMDN nomenclature in 2025.  It lists the submissions: ...

UE – MDCG 2025–10: Guidance on post-market surveillance of medical devices and in vitro diagnostic medical devices – December 2025

Theme Post-market surveillance  Target Audience Manufacturers Products concerned MD, IVD  The purpose of this guide is to:    Introduce the post-marketing surveillance (PMS) system   Describe the content and structure of the PMS plan   Outline the main activities...

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