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...
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,...
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...
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: ...
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...
Theme Innovation Target Audience Manufacturers, NB, experts panel Products concerned Innovative MD, IVD This MDCG guidance document provides guidance on Breakthrough Device (BtX) status under the Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical...
Theme Master UDI-DI Target Audience Manufacturers Products concerned Contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles This MDCG guide provides guidelines for the implementation of the UDI-DI master for spectacle frames,...
Theme Labelling Target Audience Manufacturers Products concerned Contact lenses and spectacle frames, spectacle lenses and ready-to-wear reading spectacles The MDCG has published a document on the timetable for implementing the UDI-DI Master for contact lenses,...
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...
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...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
