can be appraised critically, the results can be verified, and the search reproduced if necessary. 重要的是文献检索记录到可以挑剔评价的程度，搜索结果是可以验证的，必要时搜索复制。
Abstracts lack sufficient detail to allow issues to be evaluated thoroughly and independently, but may be sufficient to allow a first evaluation of the relevance of a paper. Copies of the full text papers and documents should be obtained for the appraisal stage.
摘要缺乏允许问题彻底、独立评估足够的细节，但对第一次评价论文的相关性是足够的。在评价阶段论文和文件全文应获得。
The literature search protocol(s), the literature search report(s), and full text copies of relevant documents, become part of the clinical evidence and, in turn, the technicaldocumentation for the medical device. 文献检索方案、文献检索报告和有关文件的全文，成为临床证据的一部分，依次，成为医疗设备的技术文档。 9. Appraisal of pertinent data (Stage 2) 数据评估 9.1 General considerations总则
In order to determine the value of the data identified in stage 1, the evaluators should appraise each individual document in terms of its contribution to the evaluation of the clinical performance and clinical safety of the device.
为了确定第一阶段识别数据的价值，评估者应评价每个文档对评价设备的临床性能和临床安全的贡献。
Uncertainty arises from two sources: the methodological quality of the data, and the relevance of the data to the evaluation of the device in relation to the different aspects12 of its intended purpose. Both sources of uncertainty should be analysed to determine a weighting for each data set.
不确定性有两个来源：数据的质量和数据与设备评估的预期目的不同方面的相关性。这两个不确定性的来源应该分析来确定每个数据集的权重。
The evaluators should therefore:以下方面应评价
?identify information contained in each document, 包含每个文件的识别信息
?evaluate the methodological quality of work done by the authors and from that, the scientific validity of the information,评价 作者工作质量和信息的科学有效性
?determine the relevance of the information to the clinical evaluation, and 确定临床评价信息的相关性 ?systematically weight the contribution of each data set to the clinical evaluation.数据的权重分配 9.2. The appraisal plan 评估计划
To ensure systematic and unbiased appraisal of the data, the evaluators should set up an appraisal plan that describes the procedure and the criteria to be used for the appraisal.
确保系统和公正的评价数据，评价者应该建立一个评估计划，描述了程序和用于评估的标准 ?The appraisal plan typically includes: 评估计划包括
-criteria for determining the methodological quality and the scientific validity of each data set. 确定方法质量和数据科学有效性的标准
-criteria for determining the relevance to the clinical evaluation (relevance to the device and to the different aspects of its intended purpose). 确定临床评价相关性的标准（设备和预期用途的不同方面的相关性） -criteria for weighting the contribution of each data set to the overall clinical evaluation. 全部临床评价数据的权重标准
?The appraisal should be thorough and objective, i.e. it should identify and attribute adequate weighting both to favourable and unfavourable contents of each document.
应全面和有目的的评估，应识别和划分每个文件有利和不利内容的权重
?The criteria adopted for the appraisal should reflect the nature, history and intended clinical use of the device. They should be documented and justified on the basis of current knowledge / the state of the art, applying accepted scientific standards.
评估采用的标准应该反映设备的性质、历史和临床使用。他们应该被记录和证明在现有知识的基础上/科学水平，为公认的科学标准。
?There are many acceptable ways, both qualitative and quantitative, by which the appraisal can be carried out13. For many well established devices and lower-risk devices, qualitative data may be adequate to fulfil the requirements of the MDD and AIMDD. The evaluation criteria should be adjusted accordingly.
有许多可以接受的定性和定量方法，用来进行评估。对于许多良好的设备和较低风险的设备，定性数据可能足以满足
MDD和AIMDD的要求。评估标准应相应调整。
?The appraisal plan should be documented in the clinical evaluation report. 评估计划应该记录在临床评估报告中。
11 to the extent that it can be critically reviewed by others
12 For example different medical indications, target populations, intended users. 9.3 Conduct of the appraisal 进行评估 The evaluators should 评价者应当
?follow the pre-defined appraisal plan strictly and apply its criteria consistently throughout the appraisal; 在整个评估过程中，严格按照预先确定的评估计划和应用标准
?base their appraisal on the full text of publications and of other documents (not abstracts or summaries), so as to review all of the contents, the methodology employed, the reporting of results, the validity of conclusions drawn from the investigation or report, and evaluate any limitations and potential sources of error in the data; 评估是基于文献全文和其他文件(不是摘要或概要)，以便回顾调查或报告的所有内容、使用方法、报告结果、得出结论的有效性，并评估任何限制和错误数据的潜在来源;
?document the appraisal in the clinical evaluation report to the extent that it can be critically reviewed by others. 在临床评估报告中，评估文件在某种程度上可以由其他人批判性的评价。 9.3.1. How to evaluate methodological quality and scientific validity 如何评价方法质量和科学有效性
The evaluators should examine the methods used to generate/ collect the data and evaluate the extent to which the observed effect (performance or safety outcomes) can be considered to be due to intervention with the device or due to
评价者应该检查用于生成/收集数据的方法和评估观察效果(性能或安全结果) 的程度可以被认为是由于设备或由于 -confounding influences(e.g. the natural course of the underlying medical condition / regression to the mean, concomitant treatments) 混淆影响（自然进程、趋势回归、联合治疗） - bias偏差
- random error 偶然误差
- inadequate disclosure of information 不充分的信息 - misinterpretation 误解
Some papers considered unsuitable for demonstration of adequate performance because of poor elements of the study design or inadequate analysis may still contain data suitable for safety analysis or vice versa.
一些论文被认为不适合充分证明性能，因为可怜的研究设计因素或分析不充分可能仍然包含适用于安全分析的数据，反之亦然。
Examples of aspects that can be taken into consideration for evaluating the methodological quality and the scientific validity of the evidence are detailed below.
例子可以考虑到评价的方法学质量和科学有效性方面的证据在下面会详细进行介绍。
a. Study design of pre-market and post-market clinical investigations 上市前的研究设计和上市前的临床调查，注意事项应包含：
Considerations may need to include:
? adequacy of the sample size and power calculation 充足的样本规模和功率计算
? adequacy and relevance of endpoints (including validity of surrogate endpoints, if used) 终点的充分性和相关性 (包括替代终点的有效性，如果使用)
? adequacy of applied controls (including choice of the study type and of comparators, if applicable)应用控制的充分性（包含研究类型的选择、对照）
? prospective randomisation of patients (in case of multiple treatment arms) 患者随机
? adequacy of inclusion and exclusion criteria, and of stratification of patients (e.g. in respect to age, medical indication, severity of the condition, gender, other prognostic factors)入组和排除标准的充分性，和病人分组(如考虑年龄、医学特征、严重的状况、性别、其他后期因素)
? distribution of prognostic factors (in case of multiple groups, were the groups comparable for these factors?) 后期因素分布（假设多组，组间对比因素？）
? blinding of patients (may include use of sham devices or sham surgery), professional users, outcome assessors (blinded endpoints)
患者不知情(可能包括使用虚假的设备或虚假的手术)，专业用户，结果评估(不知情的终点)
? adequacy of the follow-up period, including if follow-up was long enough for outcomes to occur, and if
follow-up was frequent enough to detect temporary side effects and complications (such as prolonged wound healing)
足够的随访时间，包括为了得到结果的长期随访和发现暂时性的副作用和并发症的定期随访 (如延长伤口愈合) 13 For an example, refer to Appendix D of the GHTF SG5 document N2R8:2007 on Clinical Evaluation
(Appendix D: A Possible Method of Appraisal) ? reliability of the methods used for quantifying symptoms and outcomes (including validation of the methods)用于量化症状的方法和结果的可靠性(包括方法的验证) ? adequate recording and reporting of serious adverse events and device deficiencies 充分记录和报告严重不良事件和设备不足
? adequate handling of medications and concomitant interventions 适当处理药物和伴随的干预措施
? adequacy of procedures for retrieving complete information (e.g. procedures to be applied when contacts with patients are lost, disclosure of reasons for patients leaving the study, conduct of sensitivity analysis for determining if missing data affect conclusions)
程序的充分性，用于检索完整信息(例如：用于联系患者的程序丢失、患者离开研究的原因披露，决定进行灵敏度分析，如果丢失的数据影响结论)
The evaluators should verify whether clinical investigations have been defined in such a way as to confirm or refute the manufacturer's claims for the device; and whether these investigations include an adequate number of observations to guarantee the scientific validity of the conclusions.
评价者应该验证临床调查是否已经以证实或驳斥为设备制造商的声明的方式确定，以及这些调查是否包含足够数量的观察来保证结论的科学有效性。
b. Additional aspects for appraisal of the quality of clinical investigations generated and held by the manufacturer
制造商生成和持有的临床调查质量的其他方面的评价
Where a clinical investigation has been carried out by or on behalf of a manufacturer, it is expected that
documentation relating to the design, ethical and regulatory approvals, conduct, results and conclusions of the investigation needed for the clinical evaluation will be available for consideration, as appropriate. These may include:
临床调查已由制造商或其代表执行，预期文件有调查设计、伦理和监管机构的批准、执行、结果和结论，临床评估所需的都可以适当的考虑。包括：
-the clinical investigation plan; 临床调查计划
-clinical investigation plan amendments and the rationale for these changes; 计划的修正和论据变化 -case report form templates, monitoring and audit records; 病理报告范本，监察和审计记录 -the relevant ethics committee documentation; 伦理委员会的证明文件
-regulatory authority approvals as required by applicable regulations; 监管机构的批准文件 -the signed and dated clinical investigation report (for investigations that are terminated); 临床调查报告要有签字和日期（调查终止）
-the latest intermediate report available and the latest collation on serious adverse events (for investigations that are ongoing); 最新的中期报告和严重不良事件(对正在进行的调查);
-when a clinical investigation is conducted outside of the EU, an analysis whether the results are transferable to the European population; 当在欧盟以外进行临床研究，分析结果是否能转移到欧洲人口;
-a gap analysis, when a clinical investigation is conducted to standards different from EN ISO 14155; the gap analysis should contain sufficient information to be read and understood by an independent party.
当临床调查没按EN ISO 14155标准进行时，进行差距分析，差距分析应包含独立第三方可以阅读和理解的足够信息。 The clinical investigation plan sets out how the study was intended to be conducted. It contains important
information about the study design such as the selection and assignment of participants to treatment, masking (blinding of participants and investigators) and measurement of responses to treatment, which may be
important sources of bias that can be assessed and possibly discounted when trying to determine the actual performance of the device. In addition the clinical investigation plan sets out the intended participant follow-up, approaches to statistical analyses and methods for recording outcomes, which may impact on the quality, completeness and validity of results obtained for performance and safety outcomes.
临床研究计划制定了这项研究的目的是如何进行。它包含关于研究设计的重要信息，如参与者治疗的选择和分配等，掩蔽(不知情的参与者和调查人员)和对治疗反应的测量，这可能是偏差的重要来源，能被评估和确定设备的实际性能的折扣。另外，临床调查计划制定了预期的参与者随访、统计分析方法和记录结果的方法，这可能影响性能和安全结果的质量、完整性和有效性。
Also, by having the clinical investigation plan, its amendments and the clinical investigation report available, the evaluators will be able to assess the extent to which the investigation was conducted as planned and, where deviations from the original plan have occurred, the impact those deviations had on the veracity of the data generated and the conclusions that can be drawn from the investigation about the performance and safety of the device.
通过临床研究计划以及修订和临床调查报告，评估者将能够评估按计划进行调查的程度，与原计划发生的偏差，这些偏差影响从调查设备的性能和安全得出的数据和结论的真实性。
The clinical investigation report should be signed by the sponsor and the coordinating or principal investigator to provide assurance that the report is an accurate reflection of the conduct and results of the clinical investigation.
临床调查报告应有研究者和助手的签字，负责人提供保证报告是临床研究行为和的结果的真实反应。
Another important consideration of the evaluation will be to assess whether the conduct of the investigation was in accordance with applicable regulations, and in accordance with the current applicable ethical standards that have their origin in the Declaration of Helsinki. Clinical investigations not in compliance with applicable ethical standards, medical device standards (for example EN ISO 14155 or comparable standards) or regulations
should not be used for demonstration of performance and/or safety of the device. The reasons should be noted in the report.
另一个重要的评价考虑因素是评估调查的行为是否符合国家有关规定，并依照当前适用的源自《赫尔辛基宣言》的伦理标准。临床调查不符合适用的道德标准、医疗器械标准(例如EN ISO 14155或类似的标准)、法规不应该用于证实设备的性能和/或安全。原因在报告中应注释。
c. Information derived from vigilance data, device registry data, case series, patient dossiers, and other use data
信息来源于警戒数据、设备注册数据、案例系列、病人档案和其他使用数据
Evaluators need to consider significant differences between sources of information in respect to: 评价者需要考虑信息来源之间的显著差异，以下方面的：
? procedures used for retrieving information about outcomes用于检索结果信息程序 ? quality aspects of registers and patient dossiers 登记和病人档案的质量方面
In case of information based on vigilance reporting, evaluators should consider that expected undesirable side-effects and complications of devices are not reportable under the vigilance reporting system.
Under-reporting or lack of reporting of expected side effects or complications by users is common. Therefore, the vigilance system does not typically deliver adequate information about the true frequency of expected
undesirable side-effects and complications. Systematic scientific data are needed for such purposes. Vigilance data, including trend analysis, should be used for identification of unexpected risks.
基于警戒报告的信息，评估者应考虑在警戒系统中没有报告的设备不良的副作用和并发症。漏报或缺乏使用者预期的副作用或并发症的报告是常见的。因此，警戒系统通常不真实频率的提供足够预期不良副作用和并发症的信息。达到目的需要系统科学数据，警戒数据包括趋势分析，应该用于识别意外的风险。
In case of information based on device registries, case series, retrospective analyses of patient dossiers, and other use data, the retrieval of information about outcomes may be incomplete and unreliable (have all the patients been considered? are the patients representative of the use of the device? did the register/
professional lose contact with patients if they moved on to different professionals? was there a passive or active follow-up of patients by the professionals involved? for how long?). Significant differences may exist between device registries. For instance, they may offer an important or limited coverage of a country. The evaluators should take into account the possibility of patients leaving the coverage of a registry or the follow-up of a professional when experiencing serious adverse outcomes. In routine practice, there are also significant
differences in the duration of the follow-up of patients by surgeons and other professionals, and in the quality of patient dossiers and data retrieval.
根据设备的注册信息、病例系列、病人档案的回顾性分析和其他使用数据，源于结果信息的检索可能不完整的和不可靠的(所有的病人被考虑了吗？使用设备的患者有代表性吗? 注册/专业人员失去同患者的联系，如果他们换成不同的专业人士? 专业人士被动或主动参与病人的随访?多长时间?) 在设备注册之间可能存在显著差异。例如，他们可能会提供一个重要的或有限的国家。评估者应考虑患者离开的注册或专业随访的可能性，经历严重不良后果时。在日常实践中，外科医生和其他专业人士的病人随访时间，和病人档案和数据检索的质量也存在着很大差异。
For clinical experience data it is important that any reports or collations of data (e.g. the manufacturer‘s PMS reports) contain sufficient information for the evaluators to be able to undertake a rational and objective
evaluation of the information and make a conclusion about its significance with respect to the performance and safety of the device in question.