의료기기 이야기

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

[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..

▶ 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..

▶ Introduction The Regulation (EU) 2017/745 on medical devices, hereafter referred to as the MDR, is applicable to the groups of products without an intended medical purpose that are listed in Annex XVI as from the date of application of the Commission Implementing Regulation (EU) 2022/2346, hereinafter referred to as the common specifications (CS). Products without an intended medical purpose t..

This document is intended for sponsors of clinical investigations of devices conducted within the scope of the Regulation (EU) 2017/745 (MDR). This document may be supplemented in due course with further questions and answers. Throughout this document the term ꞌdeviceꞌ is used with the same meaning as in the MDR, i.e., for the purpose of the MDR, medical devices, accessories for medical devices ..

On 5 December 2023, the European Commission adopted an implementing act designating 5 EU reference laboratories (EURLs) in the field of in vitro diagnostic medical devices (IVDs). These EURLs will be involved in conformity assessment of high-risk (class D) IVDs as well as carry out certain advisory tasks. The designated EURLs together cover the following categories of class D IVDs: Hepatitis and..

MDCG에서 발행된 문서를 기반으로 제조업체와 유럽대리인을 대상으로 설문조사를 진행하고 있다. 관심이 있으신 업체의 경우에는 확인 바랍니다. ▶ 기간: 2024년 01월 15일까지 (CET 23:59:59 까지) EUSurvey - Survey (europa.eu) Study supporting the monitoring of availability of medical devices on the EU market Surveys for MD and IVD manufacturers and aut ec.europa.eu