18 May 2026 | MDCG
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,...
18 May 2026 | MDCG
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...
18 May 2026 | MDCG
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: ...
18 May 2026 | MDCG
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...
18 May 2026 | MDCG
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...
