?The risk management X documents of the device, e.g. the hazard identification list, clinical risks identified from the risk analysis. The scope of the clinical
evaluation will need data from and cross references to X
the manufacturer‘s risk management documents. The risk management
documents are expected to identify the risks associated with the device and how such risks have been addressed. The clinical evaluation is expected to address the significance of any clinical risks that remain after design risk mitigation strategies have been employed by the manufacturer.
设备的风险管理文档，如危害鉴定列表，,临床风险识别从风险分析确定。临床评估需要的数据范围和交叉引用制造商的风险管理文档。预计风险管理文档识别与该设备相关的风险以及这些风险已经解决。临床评估的意义在处理任何临床风险，设计风险降低措施后还有的风险。
?The current knowledge/ state of the art in the
corresponding medical field, such as applicable
standards and guidance documents, information relating to the medical
condition managed with the device and its natural
course, benchmark devices, other devices and medical alternatives available to the target population.
在相应的医学领域当前知识/科学水平，如适用的标准和指南文件，设备的医疗状况管理
X X
的信息和和它的自然进程、基准设备，其他设备和医疗选择提供给目标人群。
?Data source(s) and type(s) X of data to be used in the clinical evaluation.临床评价的数据源和数据类型
Data relevant to the clinical evaluation may be
generated and held by the manufacturer or available from scientific literature.临床评价的数据可能是制造商生成和持有，或来自科技文献，附加信息见8.1和附录A4 For additional information, see Section 8.1 (Data generated and held by the manufacturer), and
Appendix A4 (Sources of literature).
?Whether the manufacturer has introduced/ intends to introduce any relevant5 changes, including制造商是否介绍或引入任何变更，包括
-design changes, 设计变更
-changes to materials and manufacturing procedures, 材料和工艺变更
-changes to the information materials supplied by the manufacturer (label, IFU, available promotional materials including accompanying documents possibly foreseen by the manufacturer) or other claims,信息材料变更（标签、说明书、宣传资料等）
-and whether the claim of equivalence to an existing device is still appropriate.声明的等效设备是否还合适
?Whether there are any specific clinical concerns that have newly emerged and need to be addressed. 是否有任何新出现和需要解决的特定的临床关注点
X
X X ?PMS aspects that need6 regularly updating X in the clinical evaluation report: 临床评价报告需要定期更新PMS
-new clinical data7 available for the device under evaluation;评价设备出现新的临床数据 -new clinical data available for the equivalent device (if equivalence is claimed); 声明的等效设备出现新的临床数据
-new knowledge about known and potential hazards, risks8, performance, benefits9 and claims10, including出现已知或潜在的危害、风险、性能、收益和投诉的新知识，包括 -data on clinical hazards seen in other products (hazard due to substances and technologies); 其它产品发现的临床危害数据
-changes concerning current knowledge/ the state of the art, such as changes to applicable standards and guidance documents, new information relating to the medical condition
managed with the device and its natural course, medical alternatives available to the target population;目前的只是和科学技术方面的变化，如应用标准和指南文件等 -other aspects identified during PMS. PMS期间识别出来的其他方面
?Needs for planning PMS activities. 需要计X 划PMS活动
It is important to recognise that there is considerable diversity in the types and history of technologies used in medical devices and the risks posed by them. Many devices are developed or modified by increments, so they are not completely novel. It may be possible to draw on the clinical experience and literature reports of the
safety and performance of an equivalent device to establish the clinical evidence, thereby reducing the need for clinical data generated through clinical investigation of the device under evaluation. Similarly, it may be possible to use compliance with harmonised standards to satisfy the clinical evidence requirements for devices based on technologies with well established safety and performance characteristics.
重要的是要认识到，有相当大的多样性和历史类型的技术用于医疗设备，及其带来的风险。许多设备都是后来的人开发或修改，所以他们并不是全新的。可以根据同等设备临床经验和文献报告得出安全性和性能的临床证据，从而减少评估设备通过临床调查生成临床数据的需要。同样，尽可能按照协调标准的要求来满足设备基于技术的良好安全和性能的临床证据。
8. Identification of pertinent data (Stage 1) 识别数据
8.1 Data generated and held by the manufacturer 制造商生成或持有的数据
Data generated and held by the manufacturer typically include the following items (not a complete list): 制造商生成或持有的数据主要包括下述项目（未完全列出））
?All pre market clinical investigations 所有上市前的临床调查
?All clinical data generated from risk management activities and the PMS programmes which the manufacturer has implemented in Europe and in other countries, including the following items (not a complete list): 所有临床数据生成于制造商在欧洲和其他国家实施的风险管理活动和PMS程序，包括下列事项(未完全列出):
-PMCF studies, such as post market clinical investigations and any device registries sponsored by the manufacturer PMS研究，如制造商支持的上市后的临床调查和设备登记
- PMS reports, including vigilance reports and trend reports PMS报告（警戒报告和趋势报告） - the literature search and evaluation reports for PMS PMS的文献检索和评价报告
- incident reports sent to the manufacturer (including the manufacturer‘s own evaluation and report) 发送给制造
商的事故报告（包括制造商自己的评价和报告）
- complaints regarding performance and safety sent to the manufacturer, including the manufacturer‘s own evaluation and report 发送给制造商的关于安全和性能的投诉
- analysis of explanted devices (as far as available) 移植设备的分析 - details of all field safety corrective actions 安全领域纠正措施的细节 - use as a custom made device 作为定制设备使用
- use under compassionate use/ humanitarian exemption programs 捐助使用？ - other user reports 其他使用报告
6 Requirement according to letter 1.11.1.c of Annex X MDD, and section 1.4 AIMDD: \and its documentation must be actively updated with data obtained from the post-market surveillance….\ 7 References: Annex 1, Essential Requirements 1, 2, 5, 5a, and Annex 7 AIMDD; and Annex I, Essential Requirements 1, 3, 6, 6a, and Annex X MDD.
8 For further detail, refer to standard EN ISO 14971 and other harmonised standards. 9 For further detail, refer to standard EN ISO 14971 and other harmonised standards.
10 Claims made by the manufacturer on the clinical performance and clinical safety of the device under
evaluation. ?Relevant pre-clinical studies (e.g. bench test reports including verification and validation data) With regard to those data:
关于数据的临床前研究（实验室测试报告包括验证和验证数据）
?All data generated and held by the manufacturer need to be identified. 制造商生成或持有的需要识别的所有数据
?Complete data need to be entirely disclosed and made available to the evaluators; this includes data from Europe and other countries; it includes clinical studies as well as use data. 完整的数据需要完全披露和提供给评估者，包括来自欧洲和其他国家的数据，包括临床研究和使用数据
?All data sets should be documented (adequately summarised11, appraised, analysed and referenced) in the clinical evaluation report.
临床评价报告中的所有数据应当文件化（一般是总结、评估、分析和应用） 8.2 Data retrieved from literature 文献数据
Literature searching is used to identify data not held by the manufacturer that are needed for the clinical evaluation.文献搜索用于识别制造商不持有的数据，需要用于临床评价。
Literature searching identifies potential sources of clinical data for establishing: 文献搜索识别潜在的来源来建立临床数据
?Clinical data relevant to the device under evaluation, which are data that relate either to the device under evaluation or to the equivalent device (if equivalence is claimed).
相关设备评价的临床数据，无论是评估设备还是等效设备(如果声称等效)的数据 ?Current knowledge/ the state of the art. 目前的知识和科学水平
Includes applicable standards and guidance documents, data that relate to benchmark devices, other devices, critical components and medical alternatives or to the specific medical conditions and patient populations intended to be managed with the device. The data are typically needed in order to
包括适用的标准和指南文件，基准设备、其他设备、关键部件和医疗替代或特定的医疗条件、管理患者群体的设备的数据。数据通常是为了
-describe the clinical background and identify the current knowledge/ state of the art in the corresponding medical field, 描述临床背景和识别当前医学领域的知识/科学技术
-identify potential clinical hazards (including hazards due to substances and technologies, manufacturing procedures and impurity profiles), 识别潜在的临床危害(包括危险物质和技术、制造工艺和杂质概况)
-justify the validity of criteria used for the demonstration of equivalence (if equivalence is claimed), 证明用于验证的等效(如果声明等效)标准的有效性
- justify the validity of surrogate endpoints (if surrogate endpoints are used). 证明替代终点(如果使用替代终点)的有效性。
The following aspects should be considered for literature searching: 文献搜索应考虑以下几方面
?The searching strategy should be thorough and objective, i.e. it should identify all relevant favourable and unfavourable data. For some devices, clinical data generated through literature searching will represent the greater part (if not all) of the clinical evidence. Thus, when conducting a literature review a comprehensive search should be conducted. If a comprehensive search is not deemed necessary, reasons should be documented.
搜索方法要全面和客观，应识别所有相关有利的和不利的数据。对于某些设备，通过文献搜索生成的临床数据将产生大部分(如果不是全部)临床证据。因此，当进行文献综述时，应进行全面搜索。如果没有采取全面的搜索，原因应该记录。
?Several searches with different search criteria or focus are usually necessary to obtain the necessary data. For additional information, see Appendix A4 (Sources of literature).
运用多个不同搜索条件或关键词的搜素对获得数据是必须的。有关的更多信息，请参阅附录A4(文献的来源) ?A literature search and other retrieval of data are carried out based on a search protocol. 文献检索和其他数据检索是基于检索方案来进行。
The search protocol documents the planning of the search before execution. For additional information, see Appendix A5 (Literature search and literature review protocol, key elements) and Appendix A6 (Appraisal of clinical data - examples of studies that lack scientific validity for demonstration of adequate clinical performance and/or clinical safety).执行搜索计划前需要有搜索方案。有关的更多信息，请参阅附录A5(文献检索和文献检索方案、关键词)和附录A6(临床数据的评估-缺乏足够科学有效性的临床表现和/或临床安全的研究实例)。
?Once the searches have been executed, the adequacy of the searches should be verified and a literature search report should be compiled to present details of the execution, any deviations from the literature search protocol, and the results of the search.
一旦执行搜索，搜索的充分性应被验证和编写详细的文献检索报告，文献搜索方案的任何偏离，搜索的结果。 ?It is important that the literature search is documented to such degree that the methods