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IVDR资源中心

使用Smart Builder，抢先一步实现IVDR合规。我们的EU IVDR Smart Builder将引导您编制IVDR技术文档文件。为您节省时间并最大程度地减少导致监管审批延误的错误。

了解更多

欧盟体外诊断器械法规（2017/746 IVDR）资源中心

欧盟的体外诊断器械法规（2017/746 IVDR）已于2022年5月26日在全球第二大医疗器械市场实施。这项新法规给IVD制造商在如何获得CE认证和维持欧盟市场准入方面带来重大变化，包括分类体系的彻底修改，导致需要公告机构介入许多以前可以自我声明的器械认证。我们的IVDR资源中心提供信息和工具，以支持IVD制造商管理和实施的欧盟合规过渡策略。

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重要的IVDR合规要求和挑战

创建实现IVDR合规的可行路线图是一个复杂的过程。与之前的欧盟体外诊断医疗器械指令（IVDD）相比，IVDR引入了新的概念和更加严格的要求，包括诸如临床数据收集和可用性工程（UE）标准 等新活动，这意味着制造商现在必须解决以下问题：

  • 基于风险的分类，这将要求公告机构介入许多类型的IVD的认证
  • CE认证的产品全生命周期方法
  • 更高的上市后监测和 上市后性能跟踪（PMPF） 要求
  • 公告机构能力：您的公告机构是否计划获得IVDR指定资格？如果是，何时获得？
  • 欧盟授权代表（AR） 职能和协议的变化
  • 针对制造商、器械和其他经营者的Eudamed数据库数据提交要求

下载我们的 IVDR准备情况检查清单 ，快速评估您的新法规合规程度并确定下一步措施。

我们如何帮助您

Emergo by UL的顾问已经做好准备，全力支持您的CE认证从体外诊断医疗器械指令（IVDD）过渡到IVDR。

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体外诊断医疗器械法规（欧盟IVDR）培训

Emergo by...
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欧盟医疗器械CE认证技术文档

我们助力医疗器械和体外诊断器械公司编制技术文档和设计档案以获得CE认证。进一步了解�...
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适用于体外诊断器械（IVD）的欧盟《体外诊断器械法规》（IVDR）咨询服务与 CE 标志服务

我们可协助您准备符合欧洲 IVDR 的 CE 标志申报材料，并为 IVD 器械的认证与审批提供支持。

我们的IVDR团队

Evangeline Loh
Evangeline Loh - United States
Global Manager, Regulatory Affairs
Evangeline Loh holds one of the most senior positions in the Emergo by UL consulting group and has over 15 years of...
Ken Pilgrim
Ken Pilgrim - Canada
Manager, Regulatory Affairs
Ken Pilgrim has over 20 years of industry experience at the Manager/Director level, overseeing corporate quality systems...
Lilian Pinheiro
Lilian Pinheiro - Brazil
Consultant, Regulatory Affairs (Latin America)
Lilian Pinheiro is located in Brazil and has over 10 years of industry experience, primarily focused on high-risk IVD...
Dayeon Choi
DaYeon Choi - South Korea
Quality and Regulatory Affairs Consultant
DaYeon Choi has over 3 years of regulatory experience with in-vitro diagnostic medical devices and provided regulatory...
Sreenu Sattu
Sreenu Sattu - India
Manager Quality Assurance and Regulatory Affairs
Sreenu Sattu has over 17 years of healthcare industry experience, focusing on medical devices and in vitro diagnostic...
Luana Zerafa
Luana Zerafa - United Kingdom
Senior Consultant, Quality and Regulatory Affairs
Luana Zerafa has over 10 years of industry experience, working with medical devices and applicable regulations in all...
Roxana Cernescu
Roxana Cernescu - Germany
Senior Consultant, Quality and Regulatory Affairs
Roxana Cernescu has more than 25 years of medical device industry experience, primarily in interventional cardiology and...
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