type of surgical approach, share the same manufacturing procedures or impurities, or share other characteristics.
4.17 Incident: any malfunction or deterioration in the characteristics and/or performance of a device, as well as any inadequacy in the labelling or the instructions for use which, directly or indirectly, might lead to or might have led to the death of a patient, or user or of other persons or to a serious deterioration in their state of health. [MEDDEV 2.12/rev 8]
事件：任何设备的品质和/或性能的故障或恶化，以及标签或使用说明书中的任何不足，直接或间接，可能导致或可能已经导致病人或使用者或他人的死亡，或他们的健康状况严重恶化。
4.18 Information materials supplied by the manufacturer：for the purpose of this document, this refers to the labelling, instructions for use and the manufacturer's promotional materials for the device under evaluation. [Derived from MDD Art. 1.2.g, MDD Annex I section 13, AIMDD Art. 1.2.f, AIMDD Annex I sections 14 and 15] 制造商提供的信息材料：本文件的目的是指的是设备标签、使用说明书和制造商的宣传材料应该评估。 4.19 Intended purpose: the use for which the device is intended according to the data supplied by the
manufacturer on the labelling, in the instructions and/or in promotional materials. [MDD Art. 1.2.g, AIMDD Art. 1.2.f]
预期目的：设备的使用是根据制造商提供的数据标签、说明书和/或促销材料
4.20 Investigator: individual member of the investigation site team designated and supervised by the principal investigator at an investigation site to perform critical clinical-investigation-related procedures or to make important clinical investigation-related decisions. [EN ISO 14155:2011] 研究者：
4.21 PMCF plan: the documented, proactive, organised methods and procedures set up by the manufacturer to collect clinical data based on the use of a CE-marked device corresponding to a particular design dossier or on the use of a group of medical devices belonging to the same subcategory or generic device group as defined in Directive 93/42/EEC. The objective is to confirm clinical performance and safety throughout the expected lifetime of the medical device, the acceptability of identified risks and to detect emerging risks on the basis of factual evidence. [MEDDEV 2.12/2 rev.2] PMCF计划：
4.22 PMCF study: a study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a
device when used in accordance with its approved labelling. [MEDDEV 2.12/2 rev.2] PMCF研究：
4.23 Risk: combination of the probability of occurrence of harm and the severity of that harm. [EN ISO 14971:2012]风险：危害发生的概率和危害严重性的组合。
4.24 Risk management: systematic application of management policies, procedures and practices to the tasks of analysing, evaluating, controlling and monitoring risk. [EN ISO 14971:2012]
风险管理：系统应用管理政策、程序和实践来分析、评价、控制和监控风险的工作。 4.25 Serious adverse event: adverse event that 严重不良事件 a) led to death,
b) led to serious deterioration in the health of the subject, that either resulted in 1) a life-threatening illness or injury, or
2) a permanent impairment of a body structure or a body function, or 3) in-patient or prolonged hospitalization, or
4) medical or surgical intervention to prevent life-threatening illness or injury or permanent impairment to a body structure or a body function,
c) led to foetal distress, foetal death or a congenital abnormality or birth defect. a) 导致死亡;
b) 导致病人，使用者或他人的健康恶化: (1) 导致威胁生命的疾病或伤害;
(2) 导致人体结构或身体机能永久的损伤; (3) 要求病人住院治疗或延长住院时间
(4) 导致医疗或手术的介入从而阻止对人体结构或身体机能的永久损失; c ) 导致胎儿宫内窒息，胎儿死亡或先天不健全
NOTE: Planned hospitalization for a pre-existing condition, or a procedure required by the CIP [Clinical
Investigation Plan], without serious deterioration in health, is not considered a serious adverse event. [EN ISO 14155:2011] 在于其存在的情况下计划住院，或一个CIP(临床研究计划)过程所需的，没有严重的健康恶化，并不被视为严重不良事件。
4.26 Sufficient clinical evidence: an amount and quality of clinical evidence to guarantee the scientific validity of the conclusions.
足够的临床证据：临床证据的数量和质量保证结论的科学有效性。 5. Abbreviations 缩写词
AIMDD: Active implantable medical device directive (Council Directive 90/385/EEC amended by Directive 2007/47/EC) 有源植入医疗器械
CEAR: Clinical Evaluation Assessment Report 临床评价评估报告 CER: Clinical Evaluation Report 临床评价报告 ER: Essential Requirement 基本要求 IFU: Instructions For Use 使用说明书
MDD: Medical Device Directive (Council Directive 93/42/EEC amended by Directive 2007/47/EC) 医疗器械指令
PMS: Post Market Surveillance 上市后的监督
PMCF: Post Market Clinical Follow-Up 上市后的随访
6. General principles of clinical evaluation 临床评价的一般原则 6.1. What is clinical evaluation? 什么是临床评价
Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device and to analyse whether there is sufficient clinical evidence to confirm compliance with relevant essential requirements for safety and performance when using the device according to the manufacturer‘s instructions for use.
临床评价是一种方法论，是持续的收集、评价和分析临床数据适合医疗器械的过程，和在根据制造商的使用说明书使用设备时，分析是否有足够的临床证据来证实符合相关安全和性能的基本要求。
In exceptional cases where an instruction for use is not required, the collection, appraisal, and analysis are conducted taking into account generally recognised modalities of use.
在不需要使用说明书的特殊情况下，进行收集、评价和分析考虑普遍认可的使用形式。
The requirements for clinical evaluation apply to all classes of medical devices. The evaluation should be appropriate to the device under evaluation, its specific properties, and its intended purpose. 临床评估的要求适用于所有类别的医疗设备。评价应适合设备评估它的特定属性和预期目的。
Benefits and risks should be specified, e.g. as to their nature, probability, extent, duration and frequency. Core issues are the proper determination of the benefit/risk profile in the intended target groups and medical indications, and demonstration of acceptability of that profile based
on current knowledge/ the state of the art in the medical fields concerned.
应该定收益和风险，例如他们的种类、概率、范围、持续时间和频率。核心问题是在目标群和医学指征众测定适当效益/风险预测，和基于医疗领域现有知识/科学技术下的状况证明是可接受性，。
Clinical evaluation is a responsibility of the manufacturer and the clinical evaluation report is an element of the technical documentation of a medical device.
临床评估是制造商的责任和临床评估报告是医疗设备技术文档的一部分。
For compliance with European medical device directives 需要遵守以下欧盟的医疗器械指令 ? the clinical evaluation addresses the following Essential Requirements: 临床评价满足下述基本原则
- Annex 1 sections 1, 2, 5 of AIMDD (for active implantable medical devices), or AIMDD附录1的1、2、5，或
- Annex I sections 1, 3, 6 of MDD (for medical devices); MDD附录1的1、3、6 see Appendix A7 (Analysis of the clinical data - compliance to specific Essential Requirements);见附录A7（临床数据分析-符合特定的基本要求）
? the evaluation must follow defined and methodologically sound procedures as described in: 评价必须遵从下述的定义和方法论
- Annex 7 of AIMDD (for active implantable medical devices), or AIMDD附录7 或 - Annex X of MDD (for medical devices); MDD附录10
? where demonstration of conformity with essential requirements based on clinical data is not deemed
appropriate, an adequate justification has to be given. The justification is included in the clinical evaluation report with contents according to:
与临床数据的基本要求相符合的证明认为不合适，必须要有充足的理由。理由包含在临床评估报告中，内容根据： - Annex 7 section 1.5 of AIMDD (for active implantable medical devices), or AIMDD附录7的1.5部分，或
- Annex X section 1.1d of MDD (for medical devices). MDD附录10的1.1d部分
Conformity to the Essential Requirements can only be assumed when the following items are aligned with each other: 符合基本要求只能假定，当下面的项目互相对准的时候？
- the information materials supplied by the manufacturer (the labelling, instructions for
use, available promotional materials, including accompanying documents foreseen by the manufacturer) 制造商提供的信息（标签、说明书、促销资料，包括补充资料）
- the clinical evaluation (the device description used for the clinical evaluation, other contents of the clinical evaluation report)
临床评价（设备描述用于临床评价，临床评价报告的其他内容）
- the available clinical data (such as results of Clinical Investigations, publications, PMS studies, etc.). 获得的临床数据（临床调查结果、出版物、PMS研究等）
Particularly, evaluators should address if the following points are adequately supported by sufficient clinical evidence:
尤其是，评价者应该解决以下几点是否充分足够的临床证据来支持:
- the intended purpose described in the information materials supplied by the manufacturer (including for all medical indications);
制造商提供信息材料里描述的预期目的（包括所有的医学特征）
- the clinical performance and benefits described in the information materials supplied by the manufacturer (including, for example, any claims on product performance and safety);
制造商提供信息材料里描述的临床性能和收益（包括产品性能和安全的任何要求）
- measures for risk avoidance and risk mitigation described in the information materials supplied by the manufacturer (including, for example the declaration of the residual risks, contraindications, precautions, warnings, instructions for managing foreseeable unwanted situations);
制造商提供信息材料里描述的避免风险和降低风险的措施 (包括,例如宣称的剩余风险、禁忌症、预防措施、警告、管理可预见的意外情况的说明);
- the usability of the device for the intended users and the suitability of the information materials supplied by the manufacturer for the intended users (including, if applicable, for lay or disabled persons);
对目标用户来说，器械的可用性和制造商提供的信息资料的适用性 (包括，如果适用，外行或残疾人)
- instructions for target population groups (including, for example, pregnant women, paediatric populations). 说明目标人群(包括孕妇、婴幼儿)。
6.2. When is clinical evaluation undertaken and why is it important?