英国标准协会BSI：2025年MDR对组合产品和基于物质的设备的影响报告（英文版）

The purpose of this whitepaper is to provide an overview of the impact of the implementation of the MDR (EU) 2017/745 on combination products and substance-based devices. The content is based on the considerable experience gained by BSI since the enforcement of the legislation. While there is no legal definition for a “combination product” within any EU Legislation, it is a common term used to describe products that combine a medical device and medicinal product. The area applies to many medi