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1. Introduction The transitional provisions of Regulation (EU) 2017/745 on medical devices (MDR) have been amended by Regulation (EU) 2023/607. In particular, the transitional period has been extended from 26 May 2024 until 31 December 2027 or 31 December 2028, depending on the risk class of the device and subject to certain conditions. This document provides updated guidance as regards the appl..

INTRODUCTION  This guidance document is intended for conformity assessment bodies (CABs), notified bodies (NBs), designating authorities (DAs), and Joint Assessment Teams (JATs) involved in Regulation (EU) 2017/745 on medical devices (hereafter MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (hereafter IVDR). It should be read in conjunction with the guidance document MD..

Introduction The purpose of this guidance document is to clarify what products fall in scope of Regulation 2017/746 on in vitro diagnostic medical devices (IVDR) – also referred to as ‘qualification’ as an in vitro diagnostic medical device (IVD) or an accessory to an IVD. In order to be qualified as an IVD or an accessory to an IVD, the product must fulfil the definition in Art 2(2) or Art 2(4)..

According to Regulation (EU) 2017/746 on in vitro diagnostic medical devices (the IVDR), as part of conformity assessment of class D in vitro diagnostic medical devices (IVDs), the manufacturer must submit an application to a notified body. In addition to the assessment by the notified body, under certain conditions particular elements may be reviewed by an expert panel and/or tested by an EU re..

The EU Regulations on medical devices and in vitro diagnostic medical devices MDR, IVDR1. Extension of MDR transitional period    - 31 Dec 2027: class III, class IIb implantable    - 31 Dec 2028: Other class IIb, class IIa, class I m/s 2. Extension of IVDR transitional period    - 31 Dec 2027: devices covered by IVDD certificate and class D    - 31 Dec 2028: class C     - 31 Dec 2029: class B, c..

This guidance, relating to the application of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) addresses the classification of in vitro diagnostic medical devices (IVDs) and provides clarifications on the classification rules as set out under Annex VIII. This classification guidance also applies to diagnostic or information society services performed on EU patients or devic..

「유럽 MDR 인증획득 기업 지원」사업의 일환으로 발간한 유럽 의료기기 월간동향소식지 2024년 6월호를 게재합니다.  ▶ 세부내용수술용 메시에 대한 부작용 사례 보고서 통합을 위한 MDCG의 목표EU 인공지능법 (AIA)  유럽의료기기 월간동향 소식지_2024년 6월 – 한국의료기기협동조합 (medinet.or.kr) 유럽의료기기 월간동향 소식지_2024년 6월「유럽 MDR 인증획득 기업 지원」사업의 일환으로 발간한 유럽 의료기기 월간동향소식지 2024년 6월호를 게재합니다. 업무에 참고하시기 바랍니다.    medinet.or.kr

Introduction: scope and contents  This document aims to provide guidance on different aspects related to standards in the medical devices sector in support of the requirements laid down in the applicable EU legislation, taking into account its specificities. The contents of this document:  are not intended to be exhaustive, and must be read and used within the legal and guidance framework on EU ..

Introduction and scope This document aims to provide guidance to the authorities responsible for notified bodies (hereafter, the Designating Authorities) and joint assessment teams (JATs) when conducting: − assessments of conformity assessments bodies (CABs) that apply for designation as a notified body (NB) in the field of medical devices and/or in vitro diagnostic medical devices,− extensions ..

IntroductionThe aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence. It provides further clarification for vigilance reporting of Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repai..