-compliance with Essential Requirements (including ER1, ER3, ER6) on performance and safety of the device, including its benefit/risk profile,
符合设备性能和安全基本要求（ER1, ER3, ER6），包括利益/风险预测
-the contents of information materials supplied by the manufacturer (including the label, IFU of the device, available promotional materials, including accompanying documents possibly foreseen by the manufacturer), 制造商提供的信息资料的内容(包括标签、IFU、可用宣传材料，包括制造商可能预见的补充文件) -residual risks and uncertainties or unanswered questions (including on rare complications, long term performance, safety under wide-spread use), whether these are
acceptable for CE-marking, and whether they are required to be addressed during PMS.
剩余风险、不确定性或悬而未决的问题(包括罕见的并发症、长期性能、大规模使用的安全性)，是否这些都可被CE-marking接受，是否要求在PMS期间处理。
? Stage 4: Finalise the clinical evaluation report 完成临床评价报告
The clinical evaluation report summarises and draws together the evaluation of all the relevant clinical data documented or referenced in other parts of the technical documentation. The clinical evaluation report and the relevant clinical data constitute the clinical evidence for conformity assessment.
临床评估报告汇总和聚焦在所有相关临床数据文件的评估或技术文档的其他部分中引用。临床评估报告及相关临床数据构成符合性评估的临床证据。
Each of these stages is covered in separate sections later in this document (see the figure below). During the course of a clinical evaluation the stages are often iterative. Indeed, the appraisal and analysis stage may
uncover new information and raise new questions, with a need to widen the scope of the evaluation, refine the clinical evaluation plan, and to retrieve, appraise and analyse additional data.
每一个阶段都被单独章节覆盖，在本文的后面部分(见下图)。临床评价过程中，各阶段往往迭代。事实上，评估和分析阶段可能会发现新的信息和提出新的问题，需要扩大评估范围，完善临床评估计划,和检索、评价和分析附加的数据。
Figure: Stages of a clinical evaluation and references to sections and appendices of this document. 临床评价的步骤和参考的章节以及附录 Stage 0: 范围和计划 见章节7 附录A3 Stage 1: 数据识别 见章节8 附录A4、A5 Stage 2: 数据评估 见章节9 附录A6
Stage 3: 临床数据分析 见章节10 附录A7、A8
Stage 4: 临床评价报告含PMS、PMCF计划 见章节11 附录A9、A10 6.4. Who should perform the clinical evaluation? 谁做临床评价
The clinical evaluation should be conducted by a suitably qualified individual or a team. The manufacturer should take the following aspects into consideration:
临床评价应由有资质的个人或团队进行。制造商应考虑以下方面：
?The manufacturer defines requirements for the evaluators that are in line with the nature of the device under evaluation and its clinical performance and risks.
制造商提出评价者的要求，评价者与评价设备的性质，临床表现和风险一致。
?The manufacturer should be able to justify the choice of the evaluators through reference to their qualifications and documented experience, and to present a declaration of interest for each evaluator. 制造商必须通过参考任职资格和书面经验证明选择的评估员是合理的。
?As a general principle, the evaluators should possess knowledge of the following: 一般原则，评价者应当掌握下列知识：
-research methodology (including clinical investigation design and biostatistics); 研究方法论（包括临床调查设计和生物学统计）
-information management (e.g. scientific background or librarianship qualification; experience with relevant databases such as Embase and Medline);
信息管理（科学背景或图书管理资格，数据库相关经验，如Embase and Medline） -regulatory requirements; and 法规要求
-medical writing (e.g. post-graduate experience in a relevant science or in medicine; training and experience in medical writing, systematic review and clinical data appraisal).
医学写作（医学或相关专业研究生，医学写作的培训和经验，系统的文献搜索和数据评估）
?With respect to the particular device under evaluation, the evaluators should in addition have knowledge of: 对特定设备的评估，评估者应另外的知识
-the device technology and its application; 设备技术和应用
-diagnosis and management of the conditions intended to be diagnosed or managed by the device, knowledge of medical alternatives, treatment standards and technology (e.g. specialist clinical expertise in the relevant medical specialty).
诊断和管理条件下预期做诊断或管理的设备，医学知识的选择，治疗标准和技术(如相关医学专业专家临床经验) ?The evaluators should have at least the following training and experience in the relevant field: 评价者应当有下述相关领域的培训和经验
-a degree from higher education in the respective field and 5 years of documented professional experience; or相关领域的高等教育学位，5年的专业经验，或
-10 years of documented professional experience if a degree is not a prerequisite for a given task. 如果学位不是一个给定任务的先决条件，需要十年的专业经验记录。
There may be circumstances where the level of evaluator expertise may be less or different; this should be documented and duly justified.
可能有的情况下，评估者的专业知识水平可以减少或不同，这应该被记录和适当的调整。 7. Definition of the scope of the clinical evaluation (Stage 0) 定义临床评价的范围
Before a clinical evaluation is undertaken the manufacturer should define its scope, based on the Essential Requirements that need to be addressed from a clinical perspective and the nature and history of the device. This is also referred to as scoping.
制造商应在临床评估之前定义它的范围，根据基本要求，需要从临床的角度处理设备的性质和历史。这也称为范围。
The scope serves as a basis for further steps, including the identification of pertinent data. The manufacturer sets up a description of the device under evaluation, and a clinical evaluation plan.
范围服务于进一步措施，包括相关数据的识别。制造商建立了一个评估设备的描述，和临床评估计划。 A clinical evaluation is required to be critical4. Therefore, it needs to identify, appraise and analyse both favourable and unfavourable data.
临床评价是紧急要求的。因此，它需要识别、评价和分析都有利和不利的数据
Depending on the stage in the lifecycle of the product, considerations for setting up a clinical evaluation plan should include different aspects. Typical examples are listed below.
根据产品生命周期的阶段，考虑建立一个临床评估计划应包括不同的方面。下面列出了典型的例子。
Aspects (not an exhaustive
前 list) 方面（不是详细清单）
?The device description.设备X 描述
For additional information, see Appendix A3 (Device description - typical
contents) 附加信息附录A3 ?Whether there are any X design features of the
device, or any indications or target populations, that require specific attention. The clinical evaluation should cover any design features that pose special performance or safety
concerns (e.g. presence of medicinal, human or animal components), the intended purpose and application of the device (e.g. target treatment group and
disease, proposed warnings, contraindications,
precautions, and method of application) and the specific claims made by the manufacturer about the clinical performance and clinical safety of the device. 是否有设备的任何设计特点、适应症或目标人群,需要特别关注。临床评估应包括构成特殊性能或安全的任何设计特点(如含药、人类或动物源)，设备的目的和应用(如目标试验组和疾病、警示、禁忌症、预防措施、和应用方法)，设备临床性能和临床安全由制造商具体声明。
?Information needed for evaluation of
equivalence, if equivalence may possibly be claimed.
如果等同性被声明，等同信息需要评价
后
X
X
X