The Regulation on in vitro diagnostic medical devices applicable from 26 May 2022 will apply the same principles. To help boost innovation in the sector, the EU-wide database on medical devices (EUDAMED), supported by a new device identification system based on a unique device identifier (UDI)...
REGULATION (EU) 2017/745 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL 欧洲议会和理事会(EU)2017/745条例 of 5 April 2017 2017年4月5日 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/...
Regulation (EU) 2017/746 on medical devices, also known as the Medical Devices Regulation (MDR), is a comprehensive piece of legislation that sets out the rules and requirements for medical devices in the European Union. The regulation was adopted on April 5, 2017, and will fully apply start...
2017年2月Regulation (EU) 2017/745 on Medical Devices医疗器械法规(MDR)提案发布,同年3月,欧盟成员国一致投票表决同意MDR。2017年5月5日,欧盟Official Journal正式对外宣MDR法规内容。MDR新法规将取代现行的有源医疗器械指令Council Directive 90/385/EEC on Active Implantable Medical Devices (AIMDD) (1990)以及...
European medical devices regulation has erased advantage for firms in rolling out new innovation in Europe first, says Stryker chief
EU regulation of medical devices and pharmaceuticals in comparative perspective. Rev Policy Res 2007;24:385-405.Christa Altenstetter and Permanand, Govin, ‗The EU regulation of medical devices and pharmaceuticals in comparative perspective`, (2007) 24 Review of Policy Research 385-405....
on the Functioning of the European Union (TFEU), this Regulation harmonises the rules for the placing on the market and putting into service of medical devices and their accessories on the Union market thus allowing them to benefit from the principle of free movement of goods. As regards ...
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...
Some devices are intended to be discarded after they have been used once. However, under properly controlled conditions some such devices can be safely reused. The regulation on medical devices contains minimum requirements on reprocessing of single-use medical devices. Reprocessing may only take place...
changes with the advent of theEuropean Union Medical Device Regulation(EU-MDR) framework, a comprehensive set of regulations being implemented across Europe. It establishes more stringent requirements to mitigate the negative impact of hazardous substances in medical devices on human health or the ...