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Implementing decision - EU - 2025/1324 - EN - EUR-Lex Implementing decision - EU - 2025/1324 - EN - EUR-LexCOMMISSION IMPLEMENTING DECISION (EU) 2025/1324 of 7 July 2025 amending Implementing Decision (EU) 2019/1396 as regards certain administrative aspects related to expert panels and as regards the designation of an additional expert panel in the field of meur-lex.europa.eu

BackgroundThe introduction of the Unique Device Identification (UDI) system referred to in Article 27 of Regulation (EU) 2017/745 on medical devices (‘the MDR’) aims to ensure an adequate level of identification and traceability of medical devices. Basic UDI-DIs, UDI-DIs and UDI-PIs shall be assigned (in compliance with the rules of the designated issuing entities) by manufacturers to all device..

Introduction Software Applications (Apps) are significantly changing our way of living, helping in various aspects of our daily lives, including healthcare. Medical device software (MDSW) Apps cover an extensive variety of uses such as those intended to drive insulin pumps, detect and diagnose skin cancers (e.g. melanoma) etc. These apps are directly available on app platforms for download and u..

Scope and purpose of this document This document, which primarily targets Medical Device Software (MDSW) manufacturers, provides guidance on:• the criteria for the qualification of software falling within the scope of the Medical Device Regulations, including Medical Device Artificial Intelligence (MDAI),• the application of the classification criteria under those regulations to MDSW and• inform..

Introduction This document is intended for sponsors of performance studies of in vitro diagnostic medical devices (IVDs) conducted within the scope of the Regulation (EU) 2017/746 (IVDR). It also contains information of relevance to manufacturers providing IVDs for use in performance studies that may be sponsored by other actors, and sponsors of combined studies. Throughout this document, the te..

Introduction This document provides a first set of answers, that will be continuously developed and updated, to the most frequently asked questions related to the joint application of the AIA and the MDR or IVDR4 for manufacturers. This Frequently Asked Questions (FAQ) document is primarily aimed at (but not limited to) medical device manufacturers, notified bodies and competent authorities. All..

New MIR form - Mandatory as from Nov 2025 PMSV reporting forms - European Commission PMSV reporting formsPMSV reporting formshealth.ec.europa.eu

The European Medical Device Nomenclature (EMDN) is the nomenclature of use by manufacturers when registering their medical devices in the EUDAMED database. Founded on pre-established criteria and requirements and based on orientations provided by the Medical Device Coordination Group (MDCG), the European Commission decided in favour of the use of the ‘Classificazione Nazionale Dispositivi medici..

EUDAMED Workshop & Training ▶ 일시: 2025년 05월 21일 EUDAMED Workshop – 21 May 2025 - Stuttgart, Germany - European Commission EUDAMED Workshop – 21 May 2025 - Stuttgart, GermanyEUDAMED Workshop – 21 May 2025 - Stuttgart, Germanyhealth.ec.europa.eu

MIR PDF 7.3.1New MIR form - mandatory as from November 2025New manufacturer incident report (MIR 7.3.1. PDF form)The published MIR form is password-protected, so it may be necessary to unlock it for specific purposes (e.g. translating the form, implementing it into in-house systems).You can request the password for specific authorised uses.New manufacturer incident report XSD files and XSL files..