EUROPEAN COMMISSION
DG ENTERPRISE
Directorate G
Unit 4 - Pressure Equipment, Medical Devices, Metrology
MEDICAL DEVICES: Guidance document MEDDEV 2.12-2 |
conveyingMay 2004 |
|
GUIDELINES ON POST MARKET CLINICAL FOLLOW-UP
The prent Guidelines are part of a t 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 rvices, 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 reprentatives of interested parties in the medical devices ctor.
该指南是在实施欧盟医疗器械指令过程中所遇到问题的系列指南中的一个，这些指南与指令之间没有法律效力的关联，这些指南是在通过对利益相关方（包括主管当局、委员会服务机构、行业以及其他利益相关各方）进行详尽的征询后谨慎起草的。在这个过程中，草稿被传阅，相关的建议在文件中加以吸收。因此，该文件体现了医疗器械各相关方代表的立场。finish的过去式
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 esntial element of the premarket conformity asssment process, it is important to recognize the limitations inherent to the premarket clinical investigations. The extent of the data that can be gathered in the premarket pha does not enable the manufacturer to detect infrequent complications or problems only apparent after widespread u, or /long term performance issues. As part of the manufacturer’s quality system, a program of appropriate post market surveillance is key to identifying and investigating risks associated with the u of medical devices placed on the market.
前言：PMCF的依据及目标
本文件的目的是为制造商以及公告机构开展PMCF提供指导，以满足医疗器械指令附录II3.1，附录IV3，附录affectationV3，附录VI3.1或附录VII4所要求的上市后市场监督义务。
虽然临床证据是对上市前合格评定程序的基本要素，重要的是要认识到上市前临床调查固有的局限性。在上市前阶段所收集到的临床数据的程度不能使制造商发现罕见的并发症或是仅有在经过长期使用后才呈现的问题，以及长期的性能问题。作为制造商质量管理体系的一部分，一个适宜的上市后监督程序的关键是识别及调查与投放市场的医疗器械的使用
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 purpo. 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.
制造商应建立一个覆盖上市后监督的普遍体系，并且对于他们的每一个产品/产品范围都应有一个明确定义的上市后监督策略。
因此，PMCF是为达到这一目的可选的方法之一。例如，在对仅依靠单一的上市前临床调查（由于相对短的需求跟踪）或产品经验/警戒系统不能有效发现的紧急风险进行长期的安全跟踪及侦查期间，建立一个审查程序，它将使病人获得新的疗法。
Implementation
Post market surveillance may include a number of strategies in addition to complaint handling and vigilance :
active supervision by customer surveys,
inquiries of urs 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 the strategies.
实施
上市后监督birdcage除了处理抱怨和警械系统还可以包括很多形式，例如：尺子的英文>成考成绩在哪儿查询
1.通过顾客调查积极管理
2.用户和患者调查，
3.文献评论，
4.上市后的临床跟踪等。
在这些形式中，上市后临床跟踪通过临床研究和登记是很重要的。
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 :
• 杰西驾到innovation, when the design of the device, the material, the principles of operation, the technology, or the medical indication is new
• verity of the dia,
• nsitive 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
当对可能出现的风险和长期的安全以及性能评估的识别至关重要时，器械的上市后临床跟踪（PMCF）应该被考虑。在识别这种风险时，应考虑以下方面的准则：
珠海联合国际学院•当设备的设计，材料，操作原理，技术，或是医疗特征采用新方法
•严重的疾病，respect是什么意思
•敏感目标人群
•危险的解剖位置
•众所周知的来源于文献的风险
埃米尔是什么意思•众所周知的已上市类似器械的风险
•识别在CE认证之前的临床评估中需要很长期和/或需要通过对很多人进行测量的可接受风险。
•上市前跟进时间与产品的预期寿命之间的明显差异。
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 reprentative subt 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 :
