The Medical Device Regulation of the European Union Intensifies Focus on Clinical Benefits of Devices

被引：0

作者：

Beata Wilkinson

Robert van Boxtel

机构：

[1] Cactus Communications,

[2] Medical Device Project B.V.,undefined

来源：

Therapeutic Innovation & Regulatory Science | 2020年 / 54卷

关键词：

medical devices; MDR; Medical Device Regulation; clinical benefits; clinical evaluation; clinical evidence;

D O I：

暂无

中图分类号：

学科分类号：

摘要：

This article comments on the new approach to the clinical evaluation of medical devices in the European Union (EU), which adds consideration of intended clinical benefits to the traditional focus on safety and performance. The article also discusses types of clinical benefits that may be claimed and how evidence for them may be generated.

引用

页码：613 / 617

页数：4