의료기기 이야기

Procedures for the updates of the European Medical Device Nomenclature The European Medical Device Nomenclature (EMDN), as established by Article 26 of Regulation (EU) 2017/745 – Medical Device Regulation (MDR) and Article 23 of Regulation (EU) 2017/746 - In Vitro Diagnostic medical devices Regulation (IVDR), will be annually reviewed and updated based on the practical use of the EMDN and feedba..

The aim of this Device Specific Vigilance Guidance (DSVG) is to harmonise vigilance reporting and provide guidance for manufacturers of Specific Devices. It provides further clarification for vigilance reporting of Specific Devices to the relevant Competent Authority and should be read in conjunction with the requirements of Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2..

The first deadline for Regulation 2023/607 is rapidly approaching. Manufacturers of legacy medical devices sold in the EU market will receive a regulatory reprieve when Regulation 2023/607 System and Procedure Packs goes into effect May 26, as long as certain conditions are met. About Regulation 2023/607 We briefly share again the requirements for Regulation 2023/607 amending the European Medica..

In 2017, the EU introduced new rules for medical devices and in vitro diagnostics to ensure a better protection of public health and patient safety. Despite considerable progress in transitioning to these rules and the additional time given to the sector to implement them, the transition remains slow. In 2023, the Commission took measures to ensure the availability of medical devices. Today, we ..

To help medical device and IVD manufacturers understand the national language requirements under the Medical Devices Regulation (2017/745, MDR) and In Vitro Diagnostic Devices Regulation (2017/746, IVDR), the European Commission recently published two tables on its website (January 17) with links for the relevant legal provisions for each member state. The MDR and IVDR contain regulatory require..

The European Commission’s Directorate-General for Health and Food Safety (DG SANTE) - through the European Health and Digital Executive Agency (HaDEA) - has commissioned a “Study supporting the monitoring of availability of medical devices on the EU market”. The study started in December 2022 and will be running for 36 months (December 2025). The study has been contracted to a consortium led by ..

한국보건산업진흥원이 관리하고 한국의료기기협동조합에서 수행한 '의료기기 유럽 MDR 맞춤형 이론, 실습 기업 지원' 사업의 일환으로 한국의료기기협동조합에서 실시한 [의료기기 유럽인증 (CE MDR) 애로사항 조사]를 통해 수집된 질의 내용을 선별하여 그에 대한 유관기관의 답변을 정리하여 발표하였다. ▶ 주제 시험, MDR 기술문서, 품질시스템, 임상시험, 사후관리문서, 인증절차 관련사항, 미용목적기기, 체외진단의료기기 MDR Reference Guide(자주하는 질문집) 발간 및 배포 – 한국의료기기협동조합 (medinet.or.kr) MDR Reference Guide(자주하는 질문집) 발간 및 배포 medinet.or.kr

Emergo by UL 에서 MDR 관련하여 최근에 발표한 Regulation (EU) 2023/607과 관련된 내용으로 웨비나를 진행한다. ▶ 일자: 2024년 01월 18일(목) 자정 (0시, CST 기준 오전 9시) ▶ 온라인으로 45분 동안 진행 예정 ▶ 링크 Regulation EU 2023/607 Frequently Found Issues | Emergo by UL Regulation EU 2023/607 Frequently Found Issues In this complimentary webinar, our Emergo by UL subject matter expert will outline the latest insights about Regulation EU 2023/607. www.em..

[Introduction] Article 61(4) of Regulation (EU) 2017/745 on medical devices (MDR) requires clinical investigations to be performed for implantable and class III devices, except in four specific cases as outlined in: CASE 1) indents 1-3 of Article 61(4); CASE 2) Article 61(6)(a); CASE 3) Article 61(6)(b); CASE 4) Article 61(5). These four cases which are exempted from the requirement to perform c..

[Introduction] This document presents questions and answers on requirements related to importers and distributors under Regulation (EU) 2017/745 on medical devices (MDR) and Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). The term ‘devices’ will be understood to include medical devices, accessories for medical devices, products listed in Annex XVI of the MDR, in vitro dia..