欧盟委员会医疗器械协调小组（MDCG）于9月底发布了一份指南文件，旨在帮助制造商根据欧盟医疗器械法规（MDR）的要求，为植入性器械和III类器械（定制器械或试验用器械除外）制定新的安全性和临床性能综述（SSCP）。SSCP将由公告机构（NB）进行确认，并通过欧洲医疗器械数据库（Eudamed）对外公开发布。预计SSCP将成为器械使用者和医护专业人员的重要信息来源。该指南文件特别指出，针对需向患者提供植入物卡的植入性器械和预期由患者直接使用的III类器械，SSCP应有助于将由其带来的任何剩余风险和副作用告知患者。针对医护专业人员，除其他信息之外，SSCP还将提供与所涉器械相关的所有可用临床数据的临床评价结果概要，概要应客观公正，无论其是有利的、不利的和/或不确定的。但该指南文件警告称，SSCP并不用于为特定疾病的诊断或治疗提供一般性建议，也不能取代使用说明书成为确保特定器械安全使用的主要文件，亦不能取代植入物卡或其他文件上的强制性信息。然而，该指南文件指出，SSCP至少应包含与使用说明书中所包含的剩余风险和不良副作用相同的信息。该指南文件指出，“还应在SSCP中明确说明，关于副作用或剩余风险的定量数据是否与先前获得的临床数据有关（例如从器械本身的结构化前瞻性随访研究中获得的数据），或者预期发生频率是否基于科学文献系统综述。此外，如果将主动报告的事件或严重事件数据用作评估副作用或剩余风险的定量数据的来源之一，则应在SSCP中加以说明，在这种情况下，需要考虑是否存在严重漏报的情况。”MDCG称，SSCP中的信息也应完全源自器械的技术文档（TD）。该指南表示，“这些文档包括设计验证/确认报告、风险管理报告/文件、临床评价报告、上市后监督（PMS）和上市后临床跟踪（PMCF）计划和报告”。该指南文件指出，“经公告机构评估判定，若所有要求的内容均已包含在SSCP中，并准确地呈现出来，同时也与技术文档中相关文件的最新版本一致，则表明SSCP已经过公告机构确认。”该指南文件还进一步讨论了SSCP的必要章节，例如：器械和制造商的识别信息，包括基本UDI-DI 和（如已签发） SRN（单一登记号）。EC Offers MDR Guidance on New Safety and Clinical Performance Summary
The European Commission’s Medical Device Coordination Group recently released guidance to help manufacturers create a new summary of safety and clinical performance (SSCP), as required by the EU’s Medical Devices Regulation (MDR) for implantable devices and for class III devices that are not custom-made or investigational.The SSCP, which will be validated by a notified body (NB) and made publicly available via the EU database on devices known as Eudamed, is expected to be an important source of information for device users and health professionals.In particular, the guidance says the SSCP should help inform patients of any residual risks and side-effects with implantable devices for which patients will be given implant cards and class III devices intended to be used directly by patients.For health professionals, the SSCP will also provide an “objective and balanced summary of the clinical evaluation results of all the available clinical data related to the device in question, whether favourable, unfavourable, and/or inconclusive,” among other information.But the guidance warns that the SSCP is not intended to give general advice on the diagnosis or treatment of particular medical conditions, nor replace the instructions for use (IFU) as the main document to ensure the safe use of a particular device, nor will it replace the mandatory information on implant cards or other documents.However, the guidance notes that the SSCP should contain information on at least the same residual risks and undesirable side-effects as included in the IFU.“It should also be clarified in the SSCP whether quantitative data on side-effects or residual risks relate to clinical data that were obtained proactively, for example from a structured prospective follow-up study of the device itself, or if the expected frequencies come from a systematic review of the scientific literature. It should be disclosed in the SSCP if data from spontaneously reported incidents or serious incidents are used as one of the sources for estimating quantitative data on side-effects or residual risks, in which case significant under-reporting needs to be considered,” the document notes.And the information in the SSCP also should be sourced entirely from the technical documentation (TD) of the device, the MDCG says. “Examples of such documents are design verification/validation reports, the risk management report/file, the clinical evaluation report, and post-market surveillance (PMS) and post-market clinical follow-up (PMCF) plans and reports,” the guidance says.The guidance also discusses the validation of the SSCP by notified bodies (NBs).“When the NB has assessed that all the required elements are included in the draft SSCP, accurately presented and in alignment with the most current version of relevant documents in the TD, the SSCP has been validated by the NB,” the document says.The required sections of the SSCP, including the identification of the device and the manufacturer, as well as the Basic UDI-DI and, if already issued, the single registration number, are also further discussed in the document.Other classification and implementing rules related to IVDR are also included in the guidance.
原文链接：https://www.raps.org/news-and-articles/news-articles/2017/12/ec-offers-mdr-guidance-on-new-safety-and-clinical
