MEDDEV2.122上市后临床跟踪指南中英文对照版.doc

EUROPEAN COMMISSION DG ENTERPRISE Directorate G Unit 4 - Pressure Equipment, Medical Devices, Metrology MEDICAL DEVICES: Guidance document MEDDEV 2.12-2 May 2004 GUIDELINES ON POST MARKET CLINICAL FOLLOW-UP 上市后临床跟踪指南 The present Guidelines are part of a set of Guidelines relating to questions of application of EC-Directives on medical devices. They are legally not binding. The Guidelines have been carefully drafted through a process of intensive consultation of the various interested parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts were circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interested parties in the medical devices sector.本准则是一个有关的欧共体指令对医疗设备的应用问题指引的一部分。他们在法律上没有约束力。该指引已审慎草拟通过各有关方面（主管机关，委员会的服务，工业，其他有关各方）在此期间，中间草案分发和评论的文件采取了密集的磋商进程。因此，这份文件反映了有关各方的代表在该领域采取的医疗设备的位置。Foreword : Rationale and Goals of PMCF This document is intended to be a guide for manufacturers and notified bodies on how to carry out PMCF in order to fulfill post market surveillance obligation according to point 3. 1 of annex II, point 3. of annex IV, point 3 of annex V, point 3.1 of annex VI or point 4 of annex VII of medical device directive (add ref. AIMDD) While clinical evidence is an essential element of the premarket conformity assessment process, it is important to recognize the limitations inherent to these premarket clinical investigations. The extent of the data that can be gathered in the premarket phase does not enable the manufacturer to detect infrequent complications or problems only apparent after widespread use, or /long term performance issues. As part of the manufacturers quality system, a program of appropriate post market surveillance is key to identifying and investigating risks associated with the use of medical devices placed on the market.前言：PMCF的基本原理和目标本文件的目的是为制造商的指引，就如何开展PMCF为了履行市场监督义务后按3点通知机构。 1附件二点三。附件四，附件三点五，六31点附件或附件4点的医疗设备指令（七加号。AIMDD）虽然临床证据是对上市前合格评定程序的基本要素，重要的是要认识到这些固有的局限性上市前的临床调查。制造商可能在上市前阶段收集不到罕见的并发症或问题后，才广泛使用，或/长期性能问题的明显数据的程度。作为制造商的质量体系，一个适当的市场监督计划的一部分后的关键是查明和调查与对市场上使用的医疗器械相关的风险。Manufacturers should have general systems in place to cover PMS as well as having a defined PMS strategy for each of their products/product ranges Therefore, PMCF appears as a method of choice for this purpose. It will, for instance, enable patients access to new therapies while establishing a review process for long term safety follow-up and detection of possible emergent risks that cannot be adequately detected by relying solely on pre-market clinical investigations (given the relatively short follow up required) or product experience /vigilance. Implementation Post market surveillance may include a number of strategies in addition to complaint handling and vigilance : active supervision by customer surveys, inquiries of users and patients, literature reviews, Post market Clinical Follow-up, etc. Post market clinical follow-up (PMCF) through clinical studies and registries has a great importance among these strategies.制造商应建立上市后监督系统，除非每一个产品均建立了明确的PMS（上市后监督）的系统。因此，PMCF显示为所选择的这个目的的方法。它将，例如，使病人获得，而建立一个长期的安全审查程序的新疗法的后续行动和可能的，不能充分依靠市场前的仅仅临床调查中（由于较短发现突发风险检测跟进要求）或产品的经验/警惕。实施上市后监督除了处理投诉和警械系统还可以包括很多形式，例如：顾客反馈管理用户和患者调查，文献评论，上市后的临床随访等。通过临床研究和临床登记处市场的后续行动（PMCF）这些战略之间有一个非常重要的。Post Market Clinical Follow-up (PMCF) should always be considered for devices where identification of possible emerging risks and the evaluation of long term safety and performance are critical. In identifying such emerging risk, the following criteria should be taken into account : innovation, when the design of the device, the material, the principles of operation, the technology, or the medical indication is new severity of the disease, sensitive target population risky anatomical location well known risk from the literature well known risk of similar marketed devices Identification of an acceptable risk during pre-CE clinical evaluation, which should be monitored in a longer term and/or through a larger population. Obvious discrepancy between the premarket follow up timescales and the expected life of the product 上市后监督（PMCF）可视为对设备可能出现的风险和长期的安全和性能评价。在识别这种新出现的风险，应考虑到下面的标准：该设备采用新的设计，材料，操作准则，技术，或者是新的医学特征严重的疾病，敏感目标人群危险的解剖位置文献发表的风险已上市类似设备存在风险确认在一个CE前临床评价可接受的风险，应长期和/或监测更多的临床人员。临床使用时间和产品的预期寿命的差别。All PMCF should be planned. The PMCF plan can take the form of extended follow-up of patients enrolled in the pre-market trials, and / or a prospective study of a representative subset of patients after the device is placed on the market. It can also take the form of open registries. This plan will need to take into account : Results of the clinical investigation including Adverse events identified Average life expectancy of the device The claims made by the manufacturer for the device Performances for which equivalence is claimed New information becoming available PMCF, when carried out, must always be performed for the use of the product within its intended indications according to Instructions for use. National regulations on post market clinical studies must be taken into account.所有PMCF应计划。该PMCF计划可以采取病人后续的观察形式，包括市场前的评审，和/或设备已投放市场后有代表性病人的前瞻性研究，可以采取开放登记表格，这个计划将需要考虑到：临床调查，包括确定的不良事件结果设备的平均预期寿命设备制造商声明声明的性能适当可用的新信息实施PMCF时，必须始终依据产品的预定适用范围内按使用说明使用。对上市后的临床研究必须考虑到相应国家的法规。The involved Notified Body should review the appropriateness of the manufacturers general PMS procedures, incorporating PMCF, as relevant, as well their PMCF plan(s) and results for specific products as part of conformity assessment procedures and quality management system auditing The follow up duration should take into account the average life expectancy of the product in its indication. Therefore, in case of a device subject to short term premarket follow up and intended to stay in the patient for its lifetime, a longer follow up will be required. PMCF will not be required for products for which the long term clinical performance and safety is already known from previous use of the device. In the case the assessment of a product is performed through the concept of equivalence , PMCF should always be considered .所涉及的公告机构应审查合格评定程序和质量管理体系，制造商的一般PMS的程序是否恰当，以及他们的PMCF计划（s）和特定产品的审计结果 随访时应考虑到其标志产品的平均预期寿命。因此，如果在一个设备在上市前跟进时间较短，并打算留在患者一生中，一个较长的病人会跟进是必须。 对需要长期临床观察和安全设备已经已知的产品不需要PMCF。在情况下可以通过等效的原则对个产品进行评估，PMCF应始终考虑。Post Market clinical Requirements (Risk based matrix) The following table sets out a triage approach and suggests general advice for the evaluation of products under different circumstances. Notified bodies should be part of the decision making with the manufacturer if applicable.上市后的临床需求（基于风险模型）下表列出了一个分类方式，并建议在不同情况下对产品进行评价的一般意见。通告机构应当是制造商作出判断是否适用的一部分。PMCF Product specificities产品特点Required actions需要采取的行动no PMCF Products for which the medium/long term clinical performance and safety is already known from previous use of the device , or from fully transferable experience with equivalent devices (except *) 该产品为中/长期的临床表现和安全已经从设备，从完全转让或具有同等设备（除*以前使用已知的经验） All received complaints and adverse events data shall be systematically reviewed, and all product related adverse events such as those described in Annex II 3.1 of the MDD must be notified to the relevant Competent Authority (ies). This includes all sources of information known by the manufacturer, including published literature. Monitoring of postmarket performance should take into account relevant data publicly available with similar devices especially when the CE marking was based on equivalence. 所有收到的投诉及不良反应的数据，应系统地评价，以及所有与产品相关的，如附件二3.1 MDD的描述的不良反应事件，必须预先通知有关主管部门（们）。这包括由制造商已知信息，包括出版文献的所有来源。上市后的监测应考虑到相关数据，特别是基于等价基础公开与CE标志时。PMCF Always considered for devices where identification of possible emerging risks and the evaluation of long term safety and performance are critical (*)Products quoted as equivalent devices where reference product is subjected to PMCF可能出现新的风险识别、安全和性能需要长期的评估的产品（*）当做“类似”的器械产品，应当参照被引用产品的PMCF。 Same as above , Plus Post-Market Clinical Follow-up (PMCF) in the form of follow up of all or a justifiable subset of patients already enrolled in pre-marketing