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MEDDEV 2.7.1:深入探讨新版医疗器械临床评价指南

阅读: 2017年12月28日

欧盟医疗器械临床评价指南MEDDEV 2.7.1第四版发布后,Emergo对新版本以及新版本对医疗器械制造商的影响进行了深入探讨。


MEDDEV 2.7.1:深入探讨新版医疗器械临床评价指南


最新版本


2016年6月发布的医疗器械临床评价指南 Meddev 2.7.1 第4版 替代了2009年12月发布的第3版。不仅第4版的长度从第3版的46页增加到了65页,而且第4版还包含了对临床数据更详细更广泛的要求。Emergo认为这正是临床评价应该做的事情。


MEDDEV属于指南文件,因此没有实施期。在现阶段,可能公告机构还是会接受基于第3版的临床评价报告(CER),但在不久的将来公告机构会希翼看到参考第4版的临床评价报告。因此,尽快开始使用新版本至关重要。这篇文章通过回答以下6个问题来帮助您了解新版的MEDDEV 2.7.1:


1.不变的是什么?变化的是什么?


一般原则仍然是制造商必须使用临床数据来证明器械符合相关的基本要求(Essential Requirements)。这些临床数据仍须基于本器械的(上市前)研究数据、其他同类器械的研究数据以及来自上市后监督(PMS)活动和警戒活动的数据。仍需对临床数据进行收集、评价和分析,但是,临床评价应该详尽到什么程度、什么评价方法是可接受的以及应该何时进行临床评价,这些内容几乎是全新的。


2.何时进行临床评价?


临床评价贯穿于医疗器械的整个生命周期,包括器械的设计阶段。临床评价是一个持续不断的过程,应当有相应的文件记录。对于临床评价报告(CER)的更新频率,制造商应给出合理说明,更新频率应根据风险、科学发展、设计变更等相关因素来确定。若通过上市后监督(PMS)收集到可能改变临床评价的相关数据,应对临床评价报告进行修订。对于创新或高风险器械,其临床评价报告应每年更新一次。对于其它器械,其临床评价报告应至少每2到5年更新一次。制造商必须对更新频率做出合理说明。


3.如何进行临床评价?


临床评价的不同阶段涉及范围和计划的定义、数据识别和每个数据集的评价、数据分析、和临床评价报告的定稿。对于大多数制造商来说,临床评价并不陌生,不过新版MEDDEV 2.7.1对这些阶段进行了详细的描述。新版指南也详述了进行临床评价的人员资质要求。另外,对于评价的范围,新版MEDDEV 2.7.1提供了更详细的要求。同时新版指南也详述了在哪里进行文献检索、如何进行文献检索、以及如何记录这些文献的收集、评价和分析过程。


4.是否仍可使用实质等同器械?


新版指南下,仍可使用实质等同器械的数据。但是“实质等同”的概念在新版指南中有了明确的定义,解读的空间相比之前要小很多。实质等同器械应当几乎是完全相同的。新版MEDDEV 2.7.1 的附录A1对实质等同性证明进行了详细说明。要证明器械的实质等同,必须考虑到器械的临床、技术和生物特性。新版MEDDEV 2.7.1的附录A1对这三方面的特性进行了详细说明。而且器械需要满足所有这三方面的特性才能证明实质等同。在此背景下,新版指南还描述了“差异”的概念,以及验证此概念所需的步骤。实际上,实质等同器械的使用将局限于同一制造商的器械,而且符合要求的器械必须来自相同的器械系列。即便是同一器械的换代产品,要想证明实质等同,也需仔细考量。


5.临床评价报告(CER)长啥样?


新版MEDDEV 2.7.1的要求非常清晰,因为它不仅要求对临床数据进行分析,而且还要求制造商透明公开所采用的方法和步骤。临床评价报告的实质部分应包括一个日志,记录该临床评价是如何进行的。相应的,临床评价报告就必须有附录,包括检索策略、全部检索结果、评价策略和结果、数据分析、以及清晰的参考文献列表。此外,所有文章和报告应可供审核员核实之用。


6.新的欧盟医疗器械法规(MDR)情况如何?


提议的医疗器械法规(MDR)的妥协统一文本已于2016年6月发布。预计在2020年的第一季度,新的医疗器械法规(MDR)将正式实施。新的医疗器械法规(MDR)要求高质量的临床评价。新版MEDDEV 2.7.1向此方向迈出了坚实的一步。按照新版MEDDEV 2.7.1进行临床评价也可帮助制造商为即将出台的立法做准备。


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英语原文

MEDDEV 2.7.1: A Closer Look at Updated Guidance on European Clinical Evaluations


July 14, 2016 by Ronald Boumans


Following the release of MEDDEV 2.7.1 with updated guidance on clinical evaluations in Europe, Emergo takes a deeper dive into some of the new version’s recommendations and their impacts on medical device manufacturers.


Latest revision


In June 2016 Revision 4 of Meddev 2.7.1; Clinical Evaluation replaced the December 2009 version. Not only did the document’s length increase from 46 in 2009 to 65 in 2016, but also includes more detailed and expansive requirements for clinical data. Emergo believes this is how a clinical evaluation should be done.


This MEDDEV is a guidance document and therefore there is no implementation period. Notified Bodies may currently accept a Clinical Evaluation Report (CER) based on Version 3, but in the immediate or near future they may expect to see reference to Version 4. Therefore it is important to start using the new version as soon as possible. This blog post guides you through this new MEDDEV by answering six questions:


1.What has (not) changed?


The general principle remains that the manufacturer must use clinical data to demonstrate compliance with relevant Essential Requirements. Such data still has to be based on (pre-market) investigations done with the subject device, as well as on investigations done with other devices and data from post-market surveillance (PMS) activities and vigilance activities where appropriate. Clinical data still need to be collected, appraised and analyzed, but the level of detail of how this should be done, what methods are acceptable and when this should be done are almost all new.


2. When to do a Clinical Evaluation?


Clinical evaluation should be conducted throughout the life cycle of a medical device, including its design stage. This is an ongoing process and documentation should reflect this. The frequency of CER updates should be justified by the manufacturer, taking into account relevant factors such as risk, scientific developments and design changes. If relevant data that could potentially change the clinical evaluation is collected through PMS, the CER should be revised. Innovative or high-risk devices should have their CERs revised annually; other devices should do this at least every two to five years. Manufacturers must justify these frequencies.


3. How to perform a clinical evaluation?


The staging of a clinical evaluation involves defining the scope and planning, data identification and appraisal of each data set; analysis of the data; and finalization of the CER. For most manufacturers this will sound familiar, but the updated MEDDEV describes these stages in detail. The requirements regarding who should perform clinical evaluations are now more detailed. The same is done regarding the scope of the evaluation; here, too, more detailed requirements provided. There is also now guidance on where and how to search for literature, and how to record the process of collecting, appraising and analyzing these articles.


4. Can equivalent devices still be used?


It is still possible to use data from an equivalent device. But the concept of “equivalence” is now clearly defined and the room for interpretation has become much smaller. Equivalent devices should be almost identical; Appendix A1 of the MEDDEV covers demonstration of equivalence. Clinical, technical and biological characteristics must be considered, and they are listed in great detail; all three groups of characteristics need to be fulfilled. The concept of “different” is described in this context, as well as the steps required to verify this concept. In practice, the use of equivalence will be limited to devices of the same manufacturer, and qualifying devices must be part of the same device family. Even identical devices of different device generations would require careful consideration in order to be acceptable as equivalent devices.


5. What will a CER look like?


The latest revision of the MEDDEV is clear in that it not only requires analysis of clinical data, but also requires manufacturers to be transparent about methods used and the steps taken. A substantial part of a CER should contain a log of how this evaluation was performed. You must therefore have appendixes that include your search strategies, full search results, appraisal strategy and results, analysis of the data, and a clear and functional list of references. All articles and reports should also be available for a reviewer to verify.


6. What about the Medical Devices Regulation?


The Compromise Consolidated text of the proposed Medical Devices Regulation (MDR) was published in June 2016. It is expected that the MDR will be applicable in the first quarter of 2020. The Regulation requires high-quality clinical evaluations. This MEDDEV takes a firm step in that direction. Working with the updated MEDDEV will help manufacturers to prepare for the coming legislation.


来自:Qserve regulatory Blog

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