什么时候开展临床评价和它为什么重要？
Clinical evaluation is conducted throughout the life cycle of a medical device, as an ongoing process.Usually, it is first performed during the development of a medical device in order to identify data that need to be generated for market access. Clinical evaluation is mandatory for initial CE-marking and it must be actively updated thereafter.
临床评价是在医疗器械使用生命周期内持续进行的过程。它首先是在医疗器械研发期间执行，以便识别市场准入需要的数据。首次获得CE-marking时，临床评价是强制要求的，在随后需要积极更新。
Clinical evaluation is necessary and important because it ensures that the evaluation of safety and performance of the device is based on sufficient clinical evidence throughout the lifetime that the medical device is on the market. This ongoing process enables manufacturers to provide notified bodies and competent authorities with sufficient clinical evidence for demonstration of conformity of the device with the Essential Requirements throughout its lifetime (for example for CE marking, fulfilment of post-market surveillance and reporting requirements, or during surveillance procedures).
临床评价是必须的和重要的，因为确保器械的安全性和有效性得到评价，通过器械在市场上整个生命周期获得的充足的临床数据。这种持续的过程使制造商提供NB和通知主管当局有足够的临床证据来证明设备在整个生命周期满足基本要求 (例如CE marking，实现上市后的监测和报告的要求，或在监测过程中)。 6.2.1. Clinical evaluation undertaken for the development of a medical device 临床评价用于医疗设备的开发
Premarket research and development are guided by clinical evaluation and risk management. Typically, manufacturers carry out clinical evaluations to
上市前的研究和开发应遵循临床评估和风险管理。通常，制造商进行临床评价 ? define needs regarding clinical safety and clinical performance of the device; 定义关于器械的临床安全性和临床性能的需要
? in case of possible equivalence to an existing device, evaluate if there are clinical data available and determine equivalence; for additional information, see Appendix A1 (Demonstration of equivalence); 尽可能的等效到现有设备，评价是否有用的临床数据和确定等效性，更多信息请参阅附录A1(等效性证实) ? carry out a gap analysis and define which data still need to be generated with the device under evaluation, whether clinical investigations are necessary and if so, to define the study
design; for additional information, see Section 10 (Analysis of the clinical data) and Appendix A2 (When should additional clinical investigations be carried out?).
执行差距分析和定义评估器械生成的数据，临床调查是否是必要的，如果是，定义研究设计；有关更多信息请参见10节(临床数据的分析)和附录A2(应当执行附加的临床调查?)。
As the initial clinical evaluation identifies the questions to be answered by a clinical investigation, the clinical evaluation process should generally commence in advance of any clinical investigation1. 作为初始临床评价确定临床调查需要回答的问题，临床评估过程通常临床调查前开始1。 6.2.2. Clinical evaluation for initial CE-marking 首次CE-marking的临床评价
Clinical evaluation is required to be carried out for the conformity assessment process leading to the CE-marking and placing on the market of a medical device. The purpose is to:
临床评估需要执行获得CE-marking和医疗设备在市场上出售的合格评定过程。其目的是: ? document that there is sufficient clinical evidence to demonstrate conformity with the Essential Requirements covering clinical performance and clinical safety; 文档中有足够的临床证据证明符合临床表现和临床安全的基本要求
? identify aspects that need to be addressed systematically during post-market surveillance (PMS), e.g. in post market clinical follow-up studies (PMCF Studies) required under the medical device directives. Typically, these aspects include estimation of residual risks and uncertainties or unanswered questions (such as rare complications, uncertainties regarding long-term performance, safety under wide-spread use).
识别方面，需要与系统的处理上市后监督(PMS)，如在医疗器械指令中的上市市场临床随访研究(PMCF研究)的要求。通常，这些方面包括剩余风险的评估和不确定性或悬而未决的问题(如罕见的并发症、不确定的长期性能、大规模使用下的安全性)。
6.2.3. Updating the clinical evaluation临床评价的更新 a. Frequency of updates 更新频率
The manufacturer should define and justify the frequency at which the clinical evaluation needs to be actively updated. 制造商需要定义和判断临床评价更新的频率
When doing so, the manufacturer should typically consider: 制造商需要重点考虑以下情况
? whether the device carries significant risks (e.g. based on design, materials, components, invasiveness, clinical procedures, high-risk anatomical locations, high-risk target populations (e.g. paediatrics, elderly), severity of disease/ treatment challenges).
设备是否有重大风险(例如基于设计、材料、组件、侵袭性、临床过程、高风险的解剖位置、高
风险的目标人群(如儿科、老年)、疾病严重程度/治疗的挑战性)。
? whether the device is well established, taking into consideration: 设备是否良好，应考虑 - innovation; 创新
- relevant changes in clinical sciences, materials sciences or other sciences related to the device under evaluation; 评估器械相关的临床科学、材料科学或其他科学的变化
- the current level of confidence in the evaluation of clinical performance and clinical safety of the device; the manufacturer should consider
目前器械在临床性能和临床安全评价中的置信水平和设备，制造商应该考虑
- the data available from clinical investigations, PMCF studies, registries or other systematic studies (including the number of devices used, if that usage was representative of the usage in the market, the results to date); 有用数据来自临床调查、PMCF研究、注册或其他系统的研究(包括使用设备的数量、设备在市场上的代表性用法、到目前为止的结果);
- the total number of devices used so far in the market, and expected reporting rates under the vigilance system.
目前在市场上使用的设备总数，和在警戒系统中预期的报告率
? whether there are risks and uncertainties or unanswered questions, in the medium or long- term, that would influence the frequency of updates.
是否有风险和不确定性或悬而未决的问题，在中或长期会影响更新的频率 ? design changes or changes to manufacturing procedures (if any). 设计变更或制造工艺变更（如有）
The clinical evaluation is actively updated: 临床评价应积极更新：
? when the manufacturer receives new information from PMS that has the potential to change the current evaluation;
当制造商从PMS收到新信息，有可能改变目前的评估
? if no such information is received, then 如果没有这种信息收到，则：
-at least annually if the device carries significant risks or is not yet well established; or 每年一次，如果设备带有重大风险或不是良好运行，或
-every 2 to 5 years if the device is not expected to carry significant risks and is well established, a justification should be provided.
每隔2-5年一次，如果设备没有重大风险，和运行良好，需要提供一个理由。
When involvement of notified bodies is required, updates are usually coordinated with the notified body. Typically, they are aligned with the timetable for surveillance audits and the renewal of the certificates.
当NB的参与被要求时，更新通常与公告机构协调。通常，他们确定监督审核的时间表和证书更新。 b. General considerations on updating the clinical evaluation 临床评价更新的总则
Manufacturers are required to implement and maintain a PMS system that routinely monitors the clinical performance and clinical safety of the device as part of their quality management system2. The scope and nature of such PMS should be appropriate to the device and its intended purpose.
制造商要求实施和维护一个PMS系统，定期地监控设备的临床表现和临床安全的质量管理系统2。PMS的范围和种类应该与设备和其预期的目的相适合。
PMS regularly generates new data (e.g. safety reports, results from published literature, registries, PMCF studies, and other data about device usage). Those data need to be evaluated for information that has a
potential to change the evaluation of the risk/benefit profile, and the clinical performance and clinical safety of the device. Those data are required to be fed into the clinical evaluation process in a timely manner.
PMS定期生成新的数据(例如安全报告、文献发表的结果、注册、PMCF研究和设备使用的数据)。这些数据需要评估的信息有可能改变风险/效益评估，以及设备的临床性能和临床安全。这些数据需要及时输入到临床评估过程。 In accordance with the Directives, the clinical evaluation and the clinical evaluation report must be actively updated with data obtained from post-market surveillance3.
根据指令，临床评价和临床评估报告必须从上市后监测获取的数据来积极更新。 When updating the clinical evaluation, the evaluators should verify: 更新临床评价，评价者应当核实
?if the benefit/risk profile, undesirable side-effects (whether previously known or newly emerged) and risk mitigation measures are still
如果效益/风险，不良的副作用(无论之前所知或新出现的)和风险降低措施仍在
-compatible with a high level of protection of health and safety and acceptable according to current knowledge/ the state of the art;
兼容高水平的健康、安全和可接受的保护，根据目前的知识/科技状态
-correctly addressed in the information materials supplied by the manufacturer of the device;
正确处理由设备制造商提供的信息资料
- correctly addressed by the manufacturer's current PMS plan; 正确处理由设备制造商提供的PMS计划
? if existing claims are still justified; 如果现有声明仍然是合理的; ? if new claims the manufacturer intends to use are justified. 如果制造商打算使用的新的声明是有合理的
While clinical evaluation requires data from PMS activities, it also generates new information that have to be fed into the PMS and risk management process. Clinical evaluation can therefore result in changes to the manufacturer‘s risk management documents, instructions for use (IFU) and PMS activities.
当临床评估需要的数据来自PMS活动，产生的新信息必须输入PMS和风险管理过程。因此临床评估可能导致改变制造商的风险管理文档，使用说明 说(IFU)和FMS活动。
If the manufacturer concludes there is not sufficient clinical evidence to be able to declare conformity with the Essential Requirements, the manufacturer will need to :
如果制造商认为没有足够的临床证据能够宣称符合基本要求，制造商需要 ? stop placing the devices on the market until conformity is restored, and 停止设备在市场上出售，直到符合性被修复，和
? take necessary corrective and preventive action. 采取必要的纠正和预防措施 6.3. How is a clinical evaluation performed? 如何进行临床评价
The clinical evaluation is based on a comprehensive analysis of available pre- and post-market clinical data relevant to the intended purpose of the device in question, including clinical performance data and clinical safety data.
临床评估基于上市前和上市后，相关设备的预期目的临床数据，包括临床性能数据和临床安全数据的综合分析。 There are discrete stages in performing a clinical evaluation: 执行临床评价有下述独立阶段
?Stage 0: Define the scope, plan the clinical evaluation (also referred to as scoping and the clinical evaluation plan).定义范围、临床评价计划（也称范围和临床评价计划） ? Stage 1: Identify pertinent data. 识别相关数据
? Stage 2: Appraise each individual data set, in terms of its scientific validity, relevance and weighting. 评价每一个数据集，其科学性、相关性和权重
? Stage 3: Analyse the data, whereby conclusions are reached about 分析数据，得出结论