例如部分可重复使用的医疗器械,原属于ClassⅠ的器械,按照新法规变成了ClassⅠ*类器械。美容类产品原MDD下不属于医疗范围,现MDR法规中已纳入; l 》确认原CE证书的发证机构是否已获得欧盟当局批准的颁发MDR证书的资质 l》 确认原CE认证时的技术文件中是否含有按照Rev4指导原则提供的临床评价报告; ...
EU2017/745,也称为医疗器械新规(MedicalDeviceRegulation,MDR),是欧盟对医疗器械的新认证法规。该法规于2017年发布,并于2021年5月26日正式生效。下面是EU2017/745医疗器械欧盟MDR认证的一些重要要求和流程: 1. 产品分类:根据MDR,医疗器械被分为四个等级(ClassI、Class IIa、Class IIb、ClassIII)。制造商需要确定其...
内容提示: 龙德出品REGULATION (EU) 2017/745 欧盟医疗器械法规龙德医疗器械工具丛书医疗器械法规中英文对照系供内部学习使用欧盟医疗器械法规(Regulation (EU)2017/745) 中英对照版EU Medical Device Regulations(Regulation (EU) 2017/745)法规原文发布日期 2017 年 5 月 5 日第一版(2019 年 7 月)主编:杨龙 赵...
The EU Medical Device Regulation and the U.S. Medical Device IndustryDaigle, BrianTorsekar, MihirJournal of International Commerce & Economics
Publication of a Factsheet onClass 1Medical Devices. March 2021: Publication ofMDCG 2021-3Questions and Answers on Custom-Made Devices. Publication ofMDCG 2021-2Guidance on state of the art of COVID-19 rapid antibody tests. Publication of anInfographic"Is your software a Medical Device?" ...
https://www.fda.gov/medical-devices/guidance-documents-medical-devices-and-radiation-emitting-products/recent-final-medical-device-guidance-documents 关注最新的医疗器械指南文件 FDA历史发布的指南文件 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/guidance-documents-medica...
Wellkang registers your products (Class I Medical Devices) with the appropriate authorities. Wellkang provides advice on the implementation of European technical regulations and guides clients through the certification procedures. Wellkang monitors and reports on new developments in European product legislati...
we understand the transformative power of innovative medical devices and the lifesaving care they offer millions of patients throughout the world. We provide conformity assessments under the European Union’s MDR (Regulation (EU) 2017/745) for a variety of the following medical device groups, inclu...
This course aims to help you to perform audits of the medical device quality management systems against the relevant requirements of the European Medical Device Regulations (EU MDR 2017/245).
purpose of specifying the scope of the designation as notified bodies in the field of medical devices under Regulation (EU) 2017/745 of the European Parliament and of the Council and in vitro diagnostic medical devices under Regulation (EU) 2017/746 of the European Parliament and of the ...