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Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746)  This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745..

After announcing the implementation of minor technical changes to the instructions for the required malfunction summary reporting format in alignment with the current version of Form FDA 3500A, the U.S. Food and Drug Administration (FDA) has finalized its 2022 draft guidance document, Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers. This resource outlines the principles ..

Emergo에서 아래와 같이 웨비나를 개최한다.​▶ 주제: Importer/Distributor MDR Requirements and Impacts for Manufacturers▶ 일시: 2024년 09월 11일 CST 09시 (한국시간: 09월 11일 23시)  Economic Operator (EO) is a term not identified in the Medical Devices Directive 93/42/EEC (MDD). The Medical Devices Regulation (EU) 2017/745 (MDR) defines in Article 2 what an EO is. There are four types of entities/organizations: manufacturer, au..

This is the first in a series of regulatory updates on the labeling standard in Mexico.What is a medical device NOM in Mexico?In simple terms, a Norma Oficial Mexicana is a Mexican regulatory standard that manufacturers meet to protect the safety of medical device, IVD and pharmaceutical users.The Mexican Secretariat of Health is the agency in charge of enforcing the national health policy an..

Description The Commission and Member States have created MDR and IVDR tables. These tables aim to help manufacturers of medical devices and in vitro diagnostic medical devices, particularly small and medium-sized ones, understand the language requirements for the information and instructions that accompany a device in a specific country. The tables provide an overview of the language requiremen..

▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR (medical device regulation), provides a possibility to use clinical data related to an equivalent device in the clinical evaluation required for a device under conformity assessment. Whilst carrying out a clinical investigation is the most direct way to generate clinical data concerning the safety an..

Background In addition to all the regulatory expertise shared and exchanged, as well as the networking, one of the benefits to RAPS Convergence conferences are the impromptu discussions. It was during one of these instances at RAPS Convergence 2023 (in the Exhibit Hall) that we were conversing with a notified body representative, who shall remain unidentified. This notified body representative p..