admin 欧盟MDR, 系统化临床评估程序（2）
“ 明确目标是一切战役的战略导向！”
在上一篇文章我们一起学习了临床评估的梗概，知道了临床评估自始至终都是一个循环罔替的过程，他伴随着医疗器械的全生命周期，也是一个必须的存在！同时我们也从MEDDEV 2.7/1(Rev.4)以及IMDRF MDCE WG/N56FINAL:2019（Clinical Evaluation）的Appendix G: A possible format for a clinical evaluation report中得到了模板（至少是个方向）。今天我们就来开始对其整个流程的共同学习！
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MDR到底对CER有什么最低要求，Stage 0阶段！
MDR在 Annex XIV Part A的Sec. 1(a)对最低要求有这样一些汇总性的描述，首先是an identification of the general safety and performance requirements that require support from relevant clinical data; 确定需要相关临床数据支持的一般安全和性能要求。说白了就是一定要通过Clinical Data来支持GSPRs!
其次是a specification of the intended purpose of the device;即预期用途的详细说明。第三是a clear specification of intended target groups with clear indications and contra-indications;详细描述患者的预期临床收益，以及相关的临床结果参数。
第四是a detailed description of intended clinical benefits to patients with relevant and specified clinical outcome parameters; 使用相关和指定的临床结果参数对患者预期的临床益处的详细描述;第五是a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects; 用于检验临床安全性的定性和定量方面的方法规范，明确涉及残余风险和副作用的确定。
第五是. a specification of methods to be used for examination of qualitative and quantitative aspects of clinical safety with clear reference to the determination of residual risks and side-effects; 详细说明用于检验临床安全性的定性与定量方法，以及残余风险、副作用的确定方法。
第六是an indicative list and specification of parameters to be used to determine, based on the state of the art in medicine, the acceptability of the benefit-risk ratio for the various indications and for the intended purpose or purposes of the device;一份指示性清单和参数说明，根据医学技术水平，用于确定各种适应症和设备预期用途的效益-风险比的可接受性;
第七是an indication how benefit-risk issues relating to specific components such as use of pharmaceutical, non-viable animal or human tissues, are to be addressed; and说明如何解决特定方面的风险利益问题，例如使用药品，非活性动物或人体组织。
第八是a clinical development plan indicating progression from exploratory investigations, such as first-in-man studies, feasibility and pilot studies, to confirmatory investigations, such as pivotal clinical investigations, and a PMCF as referred to in Part B of this Annex with an indication of milestones and a description of potential acceptance criteria.一份临床开发计划书，表明从探索性试验到验证性试验的进展，以及符合附录XIV第B部分所规定的PMCF，PMCF要列出各项里程碑与预设的接纳标准。
02
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在Stage 0阶段要先树立靶标！
根据MEDDEV 2.7/1 (Rev. 4)，Define needs regarding clinical safety and clinical performance of the device，首先要定义有关设备的临床安全和临床性能的需求。In case of possible equivalence to an existing device, evaluate if there are clinical data available and determine equivalence在可能与现有设备等效的情况下，评估是否有可用的临床数据并确定等效。Carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary要进行差距分析，通过差距分析，确认哪些资料要由临床评估获得，以及确认是否有执行临床试验的必要。
此阶段定出的靶标，也就是希望通过临床评估搞清楚的问题，是后续一切工作的基石。换句话说这里绝对是磨刀不误砍柴工，如果搞清楚靶标那么就可能不需要后续对某一具体问题所做出的大量耗时又昂贵的临床试验了。澳洲TGA里有一段话：This will allow the clinical data requirements to be established more precisely in relation to the intended purpose of a device. Precision in this analysis and the choice of selected medical indications and target populations may reduce the amount of clinical data needed from additional clinical investigations. 这将使临床数据要求更精确地建立在设备的预期用途上。这一分析的准确性和选定的医疗指征和目标人群的选择可能会减少额外临床调查所需的临床数据量。
未完待续！
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