의료기기 이야기

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..

A recent round of inspections by the Dutch Health and Youth Inspectorate (IGJ) has found that more than one-third of European Authorized Representatives (ARs) operating in the Netherlands have yet to meet all requirements applicable under the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Medical Devices Regulation (IVDR). European Authorized Representatives under supervisionE..

1. Introduction Article 120 of the Medical Device Regulation (EU) 2017/745 (MDR), as amended by Regulation (EU) 2023/607, states that devices which are covered by valid certificates issued by a notified body under the Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) or the Medical Devices Directive 93/42/EEC (MDD) may be placed on the market or put into service after the date of a..

KOTRA 바이오의료팀과 프랑크푸르트 무역관에서는 국내 의료기기 기업들의 유럽인증 전환 대응을 위해 K-바이오 데스크와 연계하여 CE-MDR 인증 컨설팅을 지원한다. CE-MDR 인증취득 준비 과정에서 궁금하신 사항들을 지원하고자 현지 컨설팅 기관과 함께 추진할 예정이다 ▶ 모집대상: CE-MDR 인증을 준비하는 국내 의료기기 제조기업▶ 지원사항: EU MDR 기초 컨설팅 (EU MDR 규정체계와 EU 지역 마케팅 노하우 전반)                     인증심사 대비 필수사항 확인 (적합성 평가 신청 준비사항 확인) 등▶ 신청기간: 2024년 05월 16일 ~ 12월 31일                     (참가기업 상시모집, 예산 소진시 조기 마감 가능)▶ 신청방법: 신청서 작성 후 메일..

This is the second in our series of regulatory updates on the EU AI Act. We discussed AIA in our first regulatory update, the EU Artificial Intelligence Act. The EU AIA introduces a comprehensive framework for AI-enabled device regulation in the EU. In this regulatory update we discuss key elements of the regulation and best practices, enforcement and oversight, AI regulatory sandboxes and real-..

한국보건산업진흥원은 국내 의료기기 글로벌 시장진출 지원의 일환으로 한국의료기기안전정보원, 범부처전주기의료기기연구개발사업단과 함께 유럽 MDR 인증 지원 세미나를 개최하고자 합니다. ▶ 일시: 2024년 06월 12일(수) 10:00~17:00▶ 장소: 엘타워 5층 오르체홀 (서울시 서초구 강남대로 213)▶ 세부내용: 유럽의료기기 인증 지원사업 설명회, MDR 전문강의, 유럽시장 진출희망 기업상담  홈 > 정보광장 > 공지사항 > 공지사항 (nids.or.kr) 한국의료기기안전정보원에 오신 걸 환영합니다의료기기산업의 최신정보를 알려드립니다. 각종 의료기기 관련 신규뉴스 및 신규정보를 알려드립니다. 새로운 소식들이 신속하게 전달될 수 있도록 노력하겠습니다. 공지사항 게시판: 제목, 작www.nids.or.kr

On April 15, 2024, the Medical Device Coordination Group (MDCG) released a new guidance document; MDCG 2024-4 Safety Reporting in Clinical Performance Studies of in Vitro Diagnostic (IVD) under the EU IVD Regulation (2017/746, IVDR). The guidance provides an in-depth look at safety reporting requirements for IVD performance studies under the IVDR. It introduces a tabular performance study Summar..

▶ Preliminary re-assessment review (PRAR) form template (MDR) - MDCG 2024-6▶ Preliminary assessment review (PAR) form template (MDR) - MDCG 2024-7▶ Preliminary assessment review (PAR) form template (IVDR) - MDCG 2024-8▶ Preliminary re-assessment review (PRAR) form template (IVDR) - MDCG 2024-9

The European Commission (EC) published its second annual overview concerning medical devices subject to the Clinical Evaluation Consultation Procedure (CECP) (Article 54) of the Medical Devices Regulation (MDR) (EU) 2017/745. This is an update to the first CECP report (April 2021-June 2022). The current report summarizes activities of expert panels to the CECP from July 2022 through June 2023. C..

What is an investigator’s brochure? The investigator’s brochure (IB) is referenced in the European Medical Devices Regulation (2017/745, MDR). However, those unfamiliar with the term IB will find it defined in Annex XV, Chapter II, Section 2. In the interest of completeness, there is a catch-all expectation in MDR Article 62 on clinical investigations. MDR Article 62(4)(m) states “the requiremen..