의료기기 이야기

A companion diagnostic device can be in vitro diagnostic (IVD) device or an imaging tool that provides information that is essential for the safe and effective use of a corresponding therapeutic product. Below is a table of cleared or approved companion diagnostic devices (in vitro and imaging). The use of an IVD companion diagnostic device is stipulated in the instructions for use in the labeli..

Medical device manufacturers selling in the European market will want to take note of the compliance requirements of several new guidance documents. It has been a busy October month for the European Commission (EC) and for stakeholders participating in the relevant Medical Devices Coordination Groups (MDCG). With the adoption of Regulation (EU) 2024/1860, not only the transitional timelines for ..

Background In Jan. 2024, the U.K. medical device regulator, the MHRA, shared a roadmap detailing how it planned to implement future medical device regulations. In September 2024, Dr. Robert Reid, Deputy Director, MHRA, Innovative Device, provided attendees at the RAPS Convergence with an update on that roadmap.On Nov. 1, Dr. Laura Squire, Chief Healthcare Quality and Access Officer, MHRA, publis..

(출처: 한국의료기기산업협회) 한국체외진단의료기기 협회에서 국내외 체외진단의료기기 최신 규제 동향 등 정보 제공을 통한 산업의 지속적 발전 및 정책 업무의 질적 향상을 위하여 교육을 개최한다. ▶ 일시: 2024년 11월 28일(목) 10:00▶ 장소: 서울 스카이뷰컨벤션 스카이홀 (서울 강남구 테헤란로 518 섬유센터 17층)▶ 참석대상: 국내 체외진단의료기기 관련 산학연병관계자 (선착순 80명)▶ 사전신청: URL or QR코드 신청▶ 주요내용: 국내외 체외진단의료기기 최신 규제 동향                     체외진단의료기기 정책발전 방안 논의  :: KOREA MEDICAL DEVICES INDUSTRY ASSOCIATION :: :: KOREA MEDICAL DEVICES INDUSTR..

It has caused years and years of regulatory uncertainty: Which EU law regulates ethylene oxide (EtO) used for sterilization of medical devices? At least for medical device and IVD manufacturers, this should be clear by now, with the publication of “MDCG 2024-13 Regulatory status of ethylene oxide (EtO) intended for the sterilization of medical  devices”.  What the MDCG document regulating steril..

식품의약품안전처에서 '체외진단의료기기 허가, 신고 심사 등에 관한 규정'을 일부개정고시하였다. ▶ 개정이유경미한 변경 관련 개정사항을 반영하고 국내에서 검체 확보가 곤란한 경우 임상적 성능시험자료 인정 확대하는 등 현행 제도를 합리적으로 개선, 보완하려는 것 ▶ 주요내용경미한 변경사항의 보고기한 연장 규정 정비국내에서 검체 확보가 곤란한 경우 임상적 성능시험자료 인정 확대  식품의약품안전처>법령/자료>법령정보>제개정고시등 - 상세보기 | 식품의약품안전처법령/자료>법령정보>제개정고시등 | 식품의약품안전처" data-og-description="「체외진단의료기기 허가·신고·심사 등에 관한 규정」 일부개정고시(제2024-69호, 2024.11.7.) 고시번호 제2024-69호 분야 분류 제개정일 2024-11..

1. Introduction The regulatory status of ethylene oxide (EtO) for the sterilisation of single-use medical devices during the manufacturing process has been discussed in relation to the Review Programme under Regulation (EU) 528/2012 on biocidal products (BPR). Ethylene oxide (EtO) is used to sterilise a wide range of medical products, such as medical devices, in vitro diagnostic medical devices ..

The demand for medication to be delivered using autoinjectors is rising internationally, responding to the increased incidence rates of chronic conditions and the emerging treatments for those chronic conditions. Autoinjectors are used to deliver medication to treat Rheumatoid Arthritis, Multiple Sclerosis, Anaphylaxis, Crohn’s Disease, among others. It is reasonable to assume that some autoinje..

1. BORDERLINE PRODUCTS: MEDICAL DEVICES / MEDICINAL PRODUCTS  1.1 IntroductionThe demarcation between the Regulation (EU) 2017/745 on medical devices (MDR) on the one hand and the Directive 2001/83/EC on the Community code relating to medicinal products for human use (MPD) on the other hand is crucial for the proper implementation of these sets of legislation and their correct interpretation and..

Introduction – Objectives of the MDR/IVDR amendment The amendment of the MDR and of the IVDR through Regulation (EU) 2024/1860 addresses three topics: 1. Regulation (EU) 2024/1860 aims to ensure a high level of patient safety and public health protection, including the mitigation of risks related to discontinuation or interruption of supply of in vitro diagnostic medical devices (IVDs) needed fo..