2025年12月16日，欧盟委员会提出简化MDR和IVDR条款负担的提案，旨在使监管框架具备未来适应性，减轻制造商负担，提高认证效率及认证程序的可预见性，同时保持高水平的公共健康保护和患者安全。在此，小编重点介绍提案对MDR的修订内容：

此提案自在《欧盟官方公报》公布之日第二十天起生效，但提案尚未透露其公布时间，让我们拭目以待。

参考资料：Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulations (EU) 2017/745 and (EU) 2017/746 as regards simplifying and reducing the burden of the rules on medical devices and in vitro diagnostic medical devices, and amending Regulation (EU) 2022/123 as regards the support of the European Medicines Agency for the expert panels on medical devices and Regulation (EU) 2024/1689 as regards the list of Union harmonisation legislation referred to in its Annex I