MDCG 由所有成员国的代表组成,由欧盟委员会的一名代表担任主席。 该文件不是欧盟委员会的文件,不能被视为反映欧盟委员会的官方立场。 本文件中表达的任何观点均不具有法律约束力,只有欧盟法院才能对欧盟法律做出具有约束力的解释。 MDCG 2019-9 安全性和临床性能总结 制造商和公告机构指南 2019 年 8 月 文档格式:DOCX
The Regulation (EU) 2017/745 on medical devices (1) requires that the manufacturer shall draw up a summary of safety and clinical performance (SSCP) for implantable devices and for class III devices, other than custom-made or investigational devices. The SSCP shall be validated by a notified ...
但是涉及该变更的SSCP更新可以等到下一次SSCP修订版发布。 This list in section 8 does not need to be included in the part of the SSCP that is intended for patients. 第8节中的这个列表不需要包含在SSCP中针对患者的部分中。 9. Revision history 修订历史 The SSCP document should include a revision ...
免费在线预览全文 Medical Device Ref. Ares(2019)6021482 - 27/09/2019 Medical Device Coordination Group Document MDCG 2019-9 MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies August 2019 This document has been endorsed by the Medical Device Coord...
Medical Device Medical Device Coordination Group Document MDCG 2019-9 MDCG 2019-9 Summary of safety and clinical performance 安全性和临床表现总结 A guide for manufacturers and notified bodies 制造商和公告机构指南 August 2019 This document has been endorsed by the Medical Device Coordination Group (...
Medical Device Medical Device Coordination Group Document MDCG 2019-9 1(24) MDCG 2019-9 Summary of safety and clinical performance A guide for manufacturers and notified bodies August 2019 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 ...
COMMISSION RECOMMENDATION (EU) 2021-1433 2021年9月1日关于新冠病毒威胁下合格评定和市场监督程序的建议 19 p. ISO 22609-2004(中文版) 41 p. EN 1276-2019 Chemical disinfectants and antiseptics - Quantitative suspension test for the evaluation of bactericidal activity o 43 p. EN 1276 2019 化...
医械宝高级版年卡会员 扫码购买 MDCG 2019-16 Rev.1 Guidance on Cybersecurity for medical devices医疗器械网络安全指南解读系列课大纲 1. 背景介绍(15min) 2. 基本网络安全概念(16min) 3.1 安全设计和制造-设计安全(16min); ...
December2019 This document has been endorsed by the Medical Device Coordination Group (MDCG) established by Article 103 of Regulation (EU) 2017/745. The MDCG is composed of representatives of all Member States and it is chaired by a representative of the European Commission.The document is not...
发文机关 江西省刘畅陈立高璐衷正 江西省王芸芸 江西省万楚婕 发文字号暂无数据 发布时间2019-07-24 政策类型公告公示 发文主题暂无心得体会 0/300 保存 上级政策 序号 政策标题 发文机关 发文时间 暂无数据 下级政策 序号 政策标题 发文机关 发文时间 暂无数据 政策关联图(1级)相似...