The EU Medical Device Regulation (MDR) and the EU In Vitro Device Regulation (IVDR) introduce substantial changes that impact all manufacturers of medical devices. However, these regulations also have implications for companies producing drug device ...
Regulatory Globe offers Expert Regulatory Affairs strategies and helpful implementation tools for medical devices. Stay updated with EU MDR, IVDR and more.
The intention of EU MDR was to make a complete overhaul of the legal regulations for medical devices to improve patient and user safety while allowing for the effective functioning of an internal market for medical device products. With more than 500,000 types of...
欧盟新版医疗器械法规【Medical Devices Regulations（简称MDR）】法规于2021年5月26日正式生效，所有进军欧洲市场的医疗器械产品都需要满足并符合MDR法规的各项要求，其中法规要求生产企业必须对产品缺陷造成的伤害负有赔偿责任，包括欧代在内的机构负有连带责任，解决方法就是向保险公司投保一份医疗器械产品责任保险。一：...
医疗器械生产企业在欧盟范围内销售时,必须符合欧盟新版医疗器械法规【Medical Devices Regulations(简称MDR)】的各项要求,包括但不限于进行技术文件评估、进行临床评估、进行风险管理并获得CE标志等。这些要求旨在确保医疗器械的安全性和有效性。 与此同时,根据MDR,制造商还需要购买产品责任保险,以弥补产品可能导致的损害或...
(2797) achieving full-scope designation under MDR and IVDR. We are also a full-scope UK Approved Body (0086) assessing medical devices and IVDs against UK legislation. We review your medical device to ensure conformity against the relevant Regulations by offering a range of flexible product ...
We are also a full-scope UK Approved Body (0086) assessing medical devices and IVDs against UK legislation. We review your medical device to ensure conformity against the relevant Regulations by offering a range of flexible product review services providing you with efficient pathways to bring your...
Medical Device Regulation (MDR) is a comprehensive set of regulations implemented by the European Union (EU) to enhance the safety and performance of medical devices. It replaces the previous Medical Device Directive (MDD) and Active Implantable Medical Device Directive (AIMDD). The MDR aims to ...
华盛昌1月31日公告,于近日收到欧盟公告机构TÜV Rheinland德国莱茵的通知,公司相关医疗产品获得欧盟医疗器械法规(Medical Device Regulations(EU) 2017/745,简称“MDR”)认证,产品名称为电子体温计、电子血压计、脉搏血氧仪。上述产品获得欧盟MDR认证,具备了进入欧盟市场的准入资格,可在认可欧盟MDR认证的区域范围内进行销...
◆ Background note on the use of the Manual on borderline and classification for medical devices under the Directives ◆ Manual on borderline and classification under Regulations (EU) 2017/745 and 2017/746 v2 - 分类界定结果(每3个月更新一次) ...