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 ...
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.Revisionhistory 修订历史 The SSCP document should include a revision hist...
The manufacturer should state in a revision history in the SSCP document whether that revision was validated by the NB. It is important and should be transparent to the public whether the SSCP document has been validated yet by the NB. See the example of a revision history in section 9 and...
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 ...
MDCG 2019-9 rev. 1_Summary of safety and clinical performance(SSCP) 发布时间:2022-5-20 | 云展网期刊杂志制作 宣传册 其他 MDCG 2019-9 rev. 1_Summary of safety and clinical performance(SSCP) 关注 SGS中国 粉丝: 0 SGS是国际公认的检验、鉴定、测试和认证机构,在世界各地共有95,000多名员工...
MedicalDevices 医疗器械 MedicalDeviceCoordination GroupDocument MDCG2019-16Rev.1 医疗器械协调小组文件 MDCG2019- 16Rev.1 GuidanceonCybersecurity formedical devices 医疗器械网络安全指南 December2019 2019.12 July 2020rev.1 2020年7 月rev . 1 This document has been endorsed by the Medical Device Coordina...
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); ...
MDCG 2019-14 关于MDR代码的解释性说明 Ref. Ares(2019)7627282 - 11/12/2019 Medical Device Medical Device Coordination Group Document MDCG 2019-14 MDCG 2019-14 Explanatory note on MDR codes December2019 This document has been endorsed by the Medical Device Coordination Group (MDCG) established...