The European Union’s (EU) Medical Device Regulation (MDR) 和 In Vitro Diagnostic Regulation (试管R), 最初于2017年5月5日由欧盟议会发布, sets forth new 和 important requirements for medical device 和 in vitro diagnostic manufacturers that distribute products in the EU.
增加监管, 扩大临床证据需求, greater requirements for 试管 manufacturers 和 intensified supervision of Notified Bodies are just some of the major changes to be considered as compared to the EU’s previous Directives: the Active Implantable Medical Devices Directive (AIMDD), Medical Device Directive (MDD) 和 In Vitro Diagnostic Directive (试管D).
这些冗长的文档导航起来可能很麻烦, particularly when trying to underst和 how the new regulations compare to the previous directives—和 more importantly, the critical steps that manufacturers should undertake to ensure conformity to MDR (m和atory compliance as of May 2021) 和 May 2022 for 试管R.
NAMSA, in an effort to assist global medical device 和 试管 manufacturers with their compliance planning, has made available several complimentary resources which can be found below.
We hope you find these tools to be beneficial as you prepare for implementation of the new regulations.
在线研讨会
MDR 临床 Evaluation Reports: Key Elements 和 Lessons Learned for Successful Compliance
了解更多试管R Implementation: First Steps for Compliance for Products Already on the 欧洲市场
了解更多Ensuring your Post-Market Surveillance Process Meets the New ISO 14971:2019 Guidance 和 MDR/试管R Requirements
了解更多欧盟MDR Part 2: How to Approach 临床 Evidence Requirements with 临床 Management & 生物统计学
了解更多欧盟MDR第1部分:当前的机遇 & 临床数据的挑战——NAMSA小组讨论
了解更多ISO 14971升级后的影响 & MDR/FDA风险管理规则的协调
了解更多MDR 10.4.我们应该做些什么来做好准备?
了解更多如何选择符合试管R标准的欧盟公告机构
了解更多试管临床试验:2019年产品推出的关键成分 & 除了
了解更多欧盟MDR:通用安全 & 医疗器械生物相容性的性能要求
了解更多欧盟MDR 2017/745: Optimizing CERs within the Medical Device Lifecycle
了解更多利用上市后监测 & 支持欧盟耐多药药物依从性的临床随访数据
了解更多指导文件
2018年7月, the 欧盟委员会 issued the following “Information to Manufacturers” in an effort to provide further clarity on new regulatory changes 和 implementation models to address the regulations:
- Draft Functional Specifications for the European Database on Medical Devices (Eudamed) ——第一个版本
- Exhaustive List of Requirements for Manufacturers of Medical Devices
- Implementation Model for Medical Devices Regulation: Step by Step 指南
- 医疗设备制造商须知
- Implementation Model for In-Vitro Diagnostic Medical Devices Regulation: Step by Step 指南
- 体外诊断医疗设备制造商情况说明书
- 现场安全通知(FSN)指导文件
