의료기기 이야기

[식약처, MFDS] 체외진단의료기기 임상적 성능시험 실시 및 관리 안내서 (민원인안내서)

식품의약품안전처에서 '체외진단의료기기 임상적 성능시험 실시 및 관리 안내서 (민원인안내서)'를 개정하였다. ▶ 개정사항문서 명칭 변경체외진단의료기기 관련 법령 개정사항 반영용어정의, 자주하는 질문, 관련 규정 추가  식품의약품안전처>법령/자료>법령정보>공무원지침서/민원인안내서>민원인안내서 - 상세보기 | 식품의약품안전처법령/자료>법령정보>공무원지침서/민원인안내서>민원인안내서 | 식품의약품" data-og-description="체외진단의료기기 임상적 성능시험 실시 및 관리 안내서 등록번호 안내서-1140-02 분야 분류 고시일 2024-12-30 등록일 2024-12-31 조회수 190 첨부파일 첨부파일 전체 다운로드 --> 체외진단의료기기 임" data-og-host="www.mfds.go.kr" da..

식품의약품안전처에서 '체외진단의료기기 표시기재 가이드라인'을 제정하였다. ▶ 세부내용기재사항: 용기, 외부포장, 첨부문서기재방식 및 요령: 일반적인 기재요령, 용기 등의 세부 기재 요령, 기재사항부착방식기재권장 및 금지사항  식품의약품안전처>법령/자료>법령정보>공무원지침서/민원인안내서>민원인안내서 - 상세보기 | 식품의약품안전처법령/자료>법령정보>공무원지침서/민원인안내서>민원인안내서 | 식품의약품" data-og-description="체외진단의료기기 표시·기재 가이드라인 등록번호 안내서-1410-01 분야 분류 고시일 2024-12-30 등록일 2024-12-31 조회수 183 첨부파일 첨부파일 전체 다운로드 --> 체외진단의료기기 표시기재 가이드" data-og-host="www.mfds.go.kr"..

Introduction Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) establishes the requirements for notified bodies involved in the conformity assessment of applicable classes of in vitro diagnostic medical devices (IVDs). Manufacturers must demonstrate that the devices conform to relevant requirements based upon objective evidence and analysis. In accordance with these conformi..

When to expect the first modules of EUDAMED to become mandatoryBy Annette van RaamsdonkAfter several meetings, consultations and a draft version, the final version of the Questions and Answers (Q&A) on EUDAMED was published a few weeks ago, in November. The Q&A document is a guidance document giving practical information on the new requirements, which followed Amendment (EU) 2024/1860, which we ..

1. Introduction Article 77(5) MDR requires that the sponsor submits to the Member States in which a clinical investigation was conducted a clinical investigation report within one year of the end of the clinical investigation or within three months of the early termination or temporary halt, irrespective of the outcome of the clinical investigation. Furthermore, the clinical investigation report..

Manufacturer Information Form on Interruption or Discontinuation of Supply of certain medical devices and certain in vitro diagnostic medical devices (as per Article 10a of Regulation (EU) 2024/1860 amending Regulation (EU) 2017/745 and Regulation (EU) 2017/746)  This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745..

BackgroundFollowing the 2021 government consultation on changes to the Medical Devices Regulations 2002 (MDR 2002), and now armed with even more information and experience, on Nov. 14, the U.K. medical device regulator, the Medicines and Healthcare products Regulatory Agency (MHRA) announced the launch of a public consultation. The MHRA solicited members of the public, including patients, medica..

BackgroundThe Medical Device Coordination Group (MDCG) has issued an update to the European vigilance guidance MDCG 2023-3. The document now covers devices regulated under the IVDR. As Emergo by UL reported last year, the initial version of MDCG 2023-3 explicitly excluded IVDs from its scope. Guidance on vigilance reporting for IVDsThe guidance now includes IVD-specific examples of incidents, se..

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 ..