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“ 临床评估之于医疗器械常山而言是越来越重要了！”
随着MDR的进一步演进和发展，欧盟市场的准入与各个医疗器械厂商对于临床评估的认知，重视并实践的程度紧密相关！因此在这一实践过程中，投入精力努力进行研究同时做到效率优先节省资源就是主要矛盾了！ 01 — 到底什么是Clinical Evaluation？ 首先我们来聊聊到底什么是Clinical Evaluation?拿MDR 2017/745的定义来说，Clinical evaluation’ means a systematic and planned process to continuously generate, collect, analyse and assessthe clinical data pertaining to a device in order to verify the safety and performance,including clinical benefits, of the device when used as intended by the manufacturer. 临床评估是一个事先规划好的系统化程序，可以持续的产生、收集、分析与评估目标医疗器械相关的临床资料，以验证目标医疗器械于预期使用上的安全、效能与临床收益！
针对上文提到的'continuously’（持续地），我们需要进一步解释临床评估在'医疗器械整个生命周期’中更新的问题。The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan in accordance with临床评价及其文件应在器械的整个生命周期内更新，并根据从实施制造商PMCF计划获得的临床数据进行更新！另外IMDRF（International Medical Device Regulator Forum）也有相关定义：Clinical evaluation is a set of ongoing activities that use scientifically sound methods for the assessment and analysis of clinical data to verify the safety,clinical performance and/or effectiveness of the medical device when used as intended by the manufacturer. 临床评估是一组持续进行的活动，使用科学可靠的方法对临床数据进行评估和分析，以验证制造商预期使用的医疗设备的安全性、临床性能和/或有效性。
这里IMDRF提到的clinical performance是个核心概念！EN ISO 14155：2011（已经被MEDDEV 2.7/1 Rev.4）的定义为：“behaviour of a medical device or response of the subject(s) to that medical device in relation to its intended use, when correctly applied to appropriate subject(s).” “在正确应用于适当的受试者时，医疗设备的行为或受试者对该医疗设备就其预期用途作出的反应。”
02 — 到底什么时候该做Clinical Evaluation? 分开来说，首先是首次执行Clinical Evaluation的时机该如何确定？Clinical evaluation is an ongoing process conducted throughout the life cycleof a medical device. It is first performed during the development of a medical device in order to identify data that need to be generated for regulatory purposes and will inform if a new device clinical investigation is necessary, together with the outcomes which need to be studied. It is then repeated periodicallyas new safety, clinical performance and/or effectiveness information about the medical device is obtained during its use. 临床评估是在医疗器械的整个生命周期中进行的一个持续的过程。它首先在医疗器械的开发过程中进行，以确定为监管目的需要生成的数据，并将告知是否有必要进行新器械临床研究，以及需要研究的结果。然后，随着在使用过程中获得关于医疗设备的新的安全性、临床性能和/或有效性信息，定期重复该测试。
这里需要解释的是，临床评估是一个观察器材生命周期、持续进行的程序。首次执行的时机应该是在研发阶段，目的是为了一是为了识别法规所需的资料，二是为了了解是否有进行临床试验的需求。 接下来我们要说的是产品上市后临床评估是需要重复的时机。The clinical evaluation and its documentation shall be updated throughout the life cycle of the device concerned with clinical data obtained from the implementation of the manufacturer’s PMCF plan in accordance with Part B of Annex XIV and the post-market surveillance plan referred to in Article 84. 这里说的是临床评估与其相应的文件，应在其全生命周期内，利用执行PMCF plan与PMS plan的过程中获取临床资料持续更新。For class III devices and implantable devices, the PMCF evaluation report and, if indicated, the summary of safety and clinical performance referred to in Article 32 shall be updated at least annually with such data.至于3类医疗器械以及可植入医疗器械，应当每年至少利用临床评估等相关资料更新一次PMCF evaluation Report和SSCP。若不在MDR规定的更新周期，一般来说当PMS发现影响产品Risk/Benefit profile，Clinical Performance和Clinical Safety时，要及时更新临床评估，(Required to be fed into the clinical evaluation process in a timely manner) (Sec 6.2.3. of MEDDEV 2.7/1 (Rev. 4)。这里需要提醒的是虽然临床评估需要来自PMS的信息与数据，但同时也会提供PMS和Risk management process的新信息，也就是说可能因为临床评估而要变更风险管理报告，使用说明书以及PMS等。
临床评估还有很多事谈，未完待续！ |
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