任何报告或收集的临床经验数据是很重要的(如制造商的PMS报告)，包含评价者能够进行合理、客观评价的足够信息，得出结论关于设备的性能和安全问题的重要意义。
Reports of clinical experience that are not adequately supported by data, such as anecdotal reports or opinions, may contribute to the evaluation, e.g. for the identification of unexpected risks, but should not be used as proof of adequate clinical performance and clinical safety of the device.
不被充分的数据支持的临床经验报告，比如趣闻报告或意见，可能促成评估，例如意外风险的识别，但不应该被充分证明设备的临床性能和临床安全。
d. Data processing and statistics数据处理和统计 Aspects to consider may include:考虑的方面包括
?suitability of methods for data processing (transforming data that are suitable for analysis), converting data to a consistent format, reconstructing missing statistics from other statistics, dealing with missing data;
合适的数据处理方法 (转换数据是合适的分析方法 )，将数据转换成统一的格式，重建丢失的数据、处理缺失数据 ?exclusions from the analysis and their implications (including disclosure and adequacy of the intention-to-treat and per-protocol populations, disclosure of results from both the intention-to-treat and the per-protocol populations);
排除分析及其影响(包括披露、意向处理和方案数量，按方案数量和意向处理的披露结果) ? adequacy of statistical methods. 统计方法的合适性 e. Quality assurance 质量保证
? compliance with Good clinical practice (GCP), such as EN ISO 14155 or equivalent standards; 符合GCP，如EN ISO 14155或等同标准
? compliance with the clinical investigation plan, independent monitoring and auditing; 符合临床调查计划、独立监察和审计
? compliance with legal requirements. 符合法规要求
While a publication in a renowned peer reviewed scientific journal is generally accepted as an indicator of scientific quality, such publication is not considered an acceptable reason for bypassing or reducing appraisal activities.
当一个出版物是著名同行评议的科学期刊是公认的科学质量的指标，不认为是避开或减少评估活动可以接受的理由。 f. Report quality 报告质量
Evaluators should consider:评估者应考虑
? adequacy of disclosure of methods used 使用适当的披露方法 ? adequacy of disclosure of data, including适当的披露数据，包含
-completeness of the reporting of adverse events and outcomes 不良事件和结果的完整报告
-sufficient description about the distribution of prognostic factors in the study population and in different study arms充分描述关于人口研究和不同的武器研究后期因素的分布规律
-disclosure of all the results the study was originally designed to generate 披露原始设计产生的所有研究结果
?validity of conclusions drawn by the authors (example: conclusions not in line with the results section of the document)
作者得出的结论的有效性(例如：结论不符合部分文档的 结果)
Possible conflicts of interest of the authors of the publications should also be taken into consideration. 可能的出版物的作者利益冲突也应考虑。
It is recognised that, where manufacturers source clinical investigation data reported in the scientific literature, the documentation readily available to the manufacturer for inclusion in the clinical evaluation is likely to be no more than the published paper itself. In case of missing information, the rating of the methodological quality of a publication may need to be downscaled.
承认制造商原文临床研究数据在科学文献中报道，包含在临床评估中制造商现成的文档不超过发表的论文。在信息缺失的情况下，出版物的方法学质量的比率可能需要缩减规模。
For additional information see Appendix A6 (Appraisal of clinical data - examples of studies that lack scientific validity for demonstration of adequate clinical performance and/or clinical safety). 更多信息参见附录A6 9.3.2. How to determine the relevance of a data set for the clinical evaluation 如何确定数据的相关性
When evaluating the relevance of collected data it is important to consider whether the data are intended to directly demonstrate adequate clinical performance and clinical safety of the device (often referred to as pivotal data), or whether the data serves an indirect supportive role. 评估收集的数据的相关性是很重要的，考虑到数据的目的是直接证实装置的临床性能和临床的安全 (通常被称为关键数据)的充分性，或是否数据提供间接的支持作用。 a. Pivotal data 关键数据
?Pivotal data must have the data quality necessary for demonstration of adequate clinical performance and clinical safety of the device under evaluation (see Appendix A6, Appraisal of clinical data - examples of studies that lack scientific validity for demonstration of adequate clinical performance and/or clinical safety); 关键数据必须有数据质量来用于证实评价设备的临床性能和临床安全的充分性（见附录A6））
?be generated either with the device under evaluation or with an equivalent device used in its intended purpose
(for an equivalent device, equivalence must be demonstrated; see Appendix A1, Demonstration of equivalence).
生成评估设备或等效设备用于预期目的 (等效设备，必须证明等效，请参阅附录A1，等效证实)。 b. Other data 其他数据
Data that are not pivotal are generally appraised and weighted for their contribution for purposes such as: 数据不是关键
?identifying and defining the current knowledge/ state of the art in the corresponding medical field, so as to define acceptability criteria for the evaluation of the benefit/risk profile and of specific side-effects of the device under evaluation;
识别和定义相关医疗领域当前的知识/科学水平，定义评价设备可接受的风险/收益评价标准和特定的副作用
?identifying hazards (including hazards due to substances and technologies), individual case reports may be used for identification of new and previously unknown hazards that are associated with the device;识别危害（包含归于物质和技术的危害），个体事件报告可用于识别与设备相关的新危害和潜在未知的危害
?justifying the validity of criteria used for the demonstration of equivalence (if equivalence is claimed); 用于证实等效的证明有效性的标准 (如果声称等效)
? justifying the validity of surrogate endpoints (if surrogate endpoints are used). 证明替代终点的有效性
? providing input for the planning of pivotal studies. 为关键研究计划提供输入
The corresponding information is, in general, summarised in a literature review section of the clinical evaluation report. 相关信息是临床评估报告中文献回顾部分的总结
c. Aspects to consider when determining relevance 确定相关性需要考虑的几个方面
The table below shows examples of aspects that could be used for determining if and in what respect data are relevant to the clinical evaluation.给出实例用于考虑数据相关性 Description 描述 Examples 实例
-device under evaluation 评价设备 To what extent are the data generated
-equivalent device等效设备 representative of the device under
-benchmark device 基准设备 evaluation?
评价设备生成的数据的代表性程度？ -other devices and medical alternatives
其他设备和医学迭代
-data concerning the medical conditions that are managed with the device关于设备医学状况被管理的数据
What aspects are covered? 哪些方面被覆盖
-pivotal performance data 关键性能数据 -pivotal safety data关键安全数据 -claims要求
-identification of hazards危害识别 -estimation and management of risks风险估计和管理
-establishment of current knowledge/ the state of the art建立当前的知识/科学水平
-determination and justification of criteria for the evaluation of the
risk/benefit relationship确定风险/利益相关的评价标准
-determination and justification of
criteria for the evaluation of acceptability of undesirable side-effects 确定可接受的不良副作用标准
-determination of equivalence 定义等效性
-justification of the validity of surrogate endpoints 判断代理终点的有效性
Are the data relevant to the intended purpose of the device or to claims about the device? 设备或声明的设备吗的预期目的相关性数据?
-representative of the entire intended purpose with all patient populations and all claims foreseen for the device under evaluation评价设备和声称已知设备代表所有患者群体的全部预期目的 -concerns specific models/ sizes/
settings, or concerns specific aspects of the intended purpose or of claims关注特定的型号/尺寸/设置，或关心预期目的某方面或要求
-does not concern the intended purpose or claims 不涉及预期目睹或要求
If the data are relevant to specific -smallest / intermediate / largest size
最小/中间/最大尺寸 aspects of the intended purpose or
claims, are they relevant to a specific -lowest / intermediate / highest dose
最低/中间/最大剂量 -model, size, or setting of the
device? 如果相关数据是特定目的或-etc. 要求，特定型号、大小或设置?
-user group?用户分组
-specialists专家
-general practitioners一般医师 -nurses护士
-adult healthy lay persons 健康成年人
-disabled persons 残疾人 -children儿童 -etc.等
-migraine prophylaxis 偏头疼预防 -treatment of acute migraine严重偏头疼治疗
-rehabilitation after stroke 中风后复原 -etc.
- pre-term infants / neonates / children /adolescents / adults / old age
早产的婴儿/新生儿/儿童/青少年/成年/老年 - female/ male
-early / late stage早期和晚期
-mild / intermediate / serious form轻度/中度/严重
-acute / chronic phase急性/慢性 - etc.
-medical indication (if applicable)?医学特征
-age group?年级分组
-gender?性别
-type and severity of the medical condition? 医疗状况类型和严重性
-range of time?时间范围
-duration of application or use长期 -number of repeat exposures周期 -duration of follow-up随访期间
9.3.3. How to weight the contribution of each data set 如何分配权重
Based on their scientific validity and relevance, the data should be weighted according to their relative contributions. 基于科学有效性和相关性，数据应该根据相对贡献给予权重。
Due to the diversity of medical devices, there is no single, well established method for weighting clinical data: 由于医疗设备的多样性，没有单一、良好的加权方法
?the evaluators should identify appropriate criteria to be applied for a specific evaluation; 评价者应该确定用于具体评价的合适标准
?these pre-defined criteria should be followed strictly by the evaluators. 评价者应严格遵守预先确定的标准
Typically, clinical data should receive the highest weighting, when generated through a well designed and monitored randomized controlled clinical investigation (also called randomised controlled trial), conducted with the device under evaluation in its intended purpose, with patients and users that are representative of the target population.
通过精心设计和监控时生成的随机对照临床研究(也称为随机对照试验) 的临床数据应给予最高的权重，评估设备的目的、病人和目标人群的代表的使用者。
Note: It is acknowledged that randomized clinical investigations may not always be feasible and/or appropriate and the use of alternative study designs may provide relevant clinical information of adequate weighting. 随机临床调查可能并不总是可行的和/或适当的，和使用的替代研究设计可以提供足够权重的相关临床信息。
When rejecting evidence, the evaluators should document the reasons (both for studies and reports that have been generated and are held by the manufacturer, and for other documents identified during Stage 1).