内容提示: I Legislative acts REGULATIONS ★ Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC ...
上海微创电生理医疗科技股份有限公司(以下简称“公司”)的产品一次性使用压力监测磁定位射频消融导管于近日获得了欧盟医疗器械法规(The Medical Device Regulations (EU) 2017/745,以下简称“MDR”)认证证书和英国医疗器械法规(The Medical Devices Regulations 2002,以下简称“MDR”)MDR认证证书,现将有关情况公告如下: ...
目前英国医疗器械产品法规——Medical Devices Regulations 2002 ,在欧盟新的MDR/IVDR的新法规出台在之前已经有了较多的协同监管内容了。例如,MHRA目前认可欧盟CE认证的产品。在前面的法规追踪报道中,英国对于新立法将在2025年7月展开实施,新的法规框架将更加健全,并与欧盟MDR/IVDR在某些内容上保持一致。
MDR是Europe Medical Regulations的缩写,也即欧盟医疗器械条例。CE MDR认证,则是该条例的新版要求下,普及的一种认证方式。以前的CE认证是基于2002/72/EC食品接触材料材质安全标准。新版MDR要求对现有CE标志做出升级,强调重点环节要求严格符合条例。企业需要在CE认证的基础上,接受更加严格的规格检测,才能获得新版的CE MDR...
Most regulations require that manufacturers, distributors or importers of devices report to regulatory authorities when they become aware of information that one of their devices may have caused or contributed to a death or serious injury, or when a recurrent malfunction is likely to cause death or...
(IMDRF), should be taken into account to promote the global convergence of regulations which contributes to a high level of safety protection worldwide, and to facilitate trade, in particular in the provisions on Unique Device Identification, general safety and performance requirements, technical ...
中英文对照新版欧洲医疗器械法规 MDR Part
Therefore, this table is not to be considered as providing any legal advice and is not to be used as a substitute to reading the regulations directly or seeking advice from a qualified expert. Find out more about how BSI can support your transition by visiting our website bsigroup.com/...
上海微创电生理医疗科技股份有限公司(以下简称“公司”)的产品一次性使用压力监测磁定位射频消融导管于近日获得了欧盟医疗器械法规(The Medical Device Regulations (EU) 2017/745,以下简称“MDR”)认证证书和英国医疗器械法规(The Medical Devices Regulations 2002,以下简称“MDR”)MDR认证证书,现将有关情况公告如下: ...
02017R0745 — EN — 24.04.2020 — 001.001 — 118 ▼C2 shall be considered to comply with the laws and regulations adopted by Member States in accordance with, respectively, Article 10a of Directive 90/385/EEC or Article 14(1) and (2) of Directive 93/42/EEC, with, respectively, point ...