临床评估报告（CER）记录了医疗设备临床评估的确定。CER包含了检查的临床数据，这些数据是从对您的设备的临床研究中收集的，或者是对显着等效设备的不同研究的后遗症。CER表明，您的设备可以实现其预期原因，而无需揭示客户和患者的其他机会。
Clinical Evaluation Report欧洲所有医疗设备都需要。您应该将您的CER呈现给您的通知机构，作为与欧洲CE技术文件的连接。该技术文件是为您的设备获取CE标记的基本进步，这是在欧洲出售或分散医疗设备所需的。188bet金搏宝滚球
医疗设备制造商需要评估自己的医疗设备或同等设备的临床数据，这些设备的安全性和临床执行是相同的。在MDR下，医疗设备制造商需要考虑三个要素以证明一个项目是相同的：生物学，技术和临床。
The MDR places great accentuation on Clinical Evaluation Reports or CERs. The Clinical Evaluation Report shapes part of the Technical File, which is the primary documentation which exhibits regulatory compliance and gives all the information about the device. Medical device organizations need to take a few measures to ensure that their CER is solid and steady and very much kept up. Clinical Evaluation Report documentation ordinarily includes 4 phases:
- 定义设备的范围，其预期用法和治疗 /诊断主张。
- Identifying and validating clinical data.
- Analyzing the data and interpreting it to check whether it meets all the necessities.
- Identifying risks and uncertainties, this might be replied during post-market surveillance (PMS).
Clinical Evaluation Report for Medical Device
A Clinical Evaluation Report (CER) for Medical Device is a document that contains the finishes of the clinical evaluation performed on the medical device dependent on all important clinical data accessible.
The CER and the clinical data are utilized together to demonstrate the similarity of the medical device to the general safety and execution necessities. The CER incorporates the details of the clinical foundation, current information, and best in class which can be utilized to assess the security and execution of the device for comparing to its expected reason.
If a settled CE marked device which is like the device under evaluation, at that point the reports of that device can be utilized to demonstrate the security and execution of the device under evaluation by asserting equivalency, given an agreement is set up between the two manufacturers. Details of the post-market activities directed are additionally given in the CER, which is utilized to address any unanswered inquiries or residual risks that are not secured by the accessible clinical data.
此外，列出了指示的各种测试的后效效期，以证明小工具的福祉和执行。在调查评估信息时，对安全性，执行，优势/危害概况的同意以及症状进行了调查，以设置对GSPR的调整。
CER的结论包括根据有关医疗领域的当前知识/最新技术以及可用的医疗替代方案的可接受性。它还包括所提供的信息材料的充分性，是否有足够的目的和降低风险措施以及任何差异。
该设备（包括其IFU）适用于预期用户和可用性方面的适用性的摘要，还包括任何差异，以及索赔的充分性及其差异。如果临床数据，信息材料，评估设备的风险管理文件之间存在一致性；应该总结差异。CER用于最终评估和证明该设备可安全用于人类，并且根据制造商的说明使用时的性能如预期的。
Also, the CER shows that the presence of the device on the market is justified because of side-effects and risks, if any, are outweighed by the benefits of the device.
Device under Clinical Evaluation
评估部分的设备旨在描述该设备，但还描述了用于CER和数据调查的技术。它应该纳入一些细分市场，包括临床评估的原因，显示平等（如果相关）以及所使用的临床信息索引。该细分市场必须解决临床评估是否取决于逻辑写作，如果临床信息适用于该设备，则将比例合法化。
Type of evaluation
Demonstration of equivalence
Data generated and held by the manufacturer
– Post-market surveillance
– Post-market clinical follow up
– Relevant Pre-clinical studies
- 生物相容性测试（生物学和临床等效性）
- 台式测试（技术和临床等效性）
– Electrical safety
– Software verification and validation
Data retrieved from literature
Summary and appraisal of clinical data
Analysis of the clinical data
– Requirement on Safety
– Requirement on acceptable benefit/risk profile
- 性能的要求
– Requirement on the acceptability of undesirable side-effects
Preparing a clinical evaluation report (CER) is time-consuming, but the report is also a living document. Therefore, you need to have a post-market surveillance plan for each medical device or device family that specifies the frequency of performing a review and update of your clinical evaluation report (CER). Depending upon the nature of your device and the amount of clinical history you have with that device, you may also need to conduct a post-market clinical follow-up study (PMCF). Any post-market surveillance that you conduct should be included as an input to the clinical evaluation report..
