MEDDEV 2.12-2 医疗器械上市后临床跟踪指南
MDD指南,MEDDEV 2.12-1 rev.8-2013.01, 医疗器械警戒系统指南
MEDICAL DEVICES: Guidance document
MEDDEV 2.12-1 rev 8 January 2013
GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM
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.
欧盟医疗器械警戒系统指南
欧盟医疗器械警戒系统指南
——杨悦汤涵令狐昌黎刘东旭译
从2008年1月1日起，欧盟开始实施新的《医疗器械警戒系统指南》（MEDDEV2.12/1-第五版，2007年4月发布，以下简称《指南》）。该《指南》是在2001年4月发布的《欧盟医疗器械指令》（MEDDEV2.12/1-第四版，以下简称《指令》）基础上修订的，修订内容包括：1.将医疗器械全球协调行动任务组（GHTF）国际法规中关于医疗器械警戒及售后监督的指南性文件予以考虑，并将其相关内容转换成适用于欧盟的条款；2.介绍了欧盟医疗器械数据库（EUDAMED）；3.根据2001年《指令》实施的经验修改了一些规范性文件。
一、《指南》简介
《指南》的主要内容有欧盟体系中医疗器械事件报告、评价及现场安全纠正措施（Field Safety Corrective Actions，以下简称FSCA），即医疗器械警戒系统的全部内容。建立医疗器械警戒系统的主要目的是通过降低事件复发率的可能性来提高对患者、器械使用者及其他人的健康和安全的保护。要达到这一目标，需有关部门通过对上报的不良事件进行评价，并利用适当的信息发布防止此类事件的重复发生或者减轻事件后果。
该《指南》旨在促进以下指令对医疗器械警戒系统所要求内容的统一应用和实施：1.有源植入式医疗器械指令（the Directive for Active Implantable Medical Devices，简称AIMD），90/385/EEC；
2.医疗器械指令（the Directive for Medical Devices，简称MDD），93/42/EEC；
CE上市后临床跟踪控制程序
CE上市后临床跟踪控制程序
编制人/日期：
审核人/日期：
批准人/日期：
修订页
目录
1.目的 (4)
2.范围 (4)
3.职责 (4)
4.程序 (4)
5.术语及定义 (4)
6.相关文件 (6)
7.相关记录 (6)
1.目的
根据MDR中附录XIV、MEDDEV 2.12-2第2版《医疗器械上市后临床跟踪研究指南》的要求，规范公司的带CE标识的医疗器械是否进行上市后临床跟踪研究以及如何进行研究，特拟定本文件。2.范围
适用于本公司医疗器械产品的CE上市后临床跟踪的制定与管理。
3.职责
3.1总经理负责CE上市后临床跟踪（PMCF）计划及评估报告的批准。
3.2管理者代表负责CE上市后临床跟踪（PMCF）计划及评估报告的审核。
3.3研发部及临床专家负责CE上市后临床跟踪（PMCF）计划及上市后临床跟踪评估报告的编制。3.4质管部负责CE上市后临床跟踪（PMCF）计划及报告的归档管理，及有关法规的更新。
3.5各相关部门按分配执行。
4.术语及定义（来源于MEDDEV 2.12-2第2版）
上市后临床跟踪研究（Post Market Clinical Follow-Up Study）:在医疗器械获得CE标记后进行的研究，旨在回答与根据其批准的标签适用时，器械的临床安全性或性能（即残余风险）相关的具体问题
5.程序
5.1CE上市后临床跟踪（PMCF）的基本要求：
上市后临床跟踪（PMCF）是更新临床评价报告的持续过程，并应加入制造商CE上市后监督计划（Post-market Surveillance plan）中，详见《CE上市后监督控制程序》。上市后临床跟踪（PMCF）的执行应当遵循PMCF计划中的规定并记录的方法。
MEDDEV 2 12-2 Chinese
EUROPEAN COMMISSION 欧盟委员会
DG ENTERPRISE DG企业
Directorate G 董事会G
Unit 4 - Pressure Equipment, Medical Devices, Metrology
第4单元-压力设备、医疗器械、计量学
医疗器械指南
该指南是指实施医疗器械EC指令中所遇到问题的系统指南中的一个。这些指令与指南之间没有法律效益的关联。这些指南是通过与各个利益方（包括主管当局，委员会服务机构，行业以及其他利益相关方）进行详尽的征询后谨慎起草的，在这个过程中，草稿有被传阅，相关的建议在文件中加以采纳。因此，此文件体现了医疗器械各相关方代表的立场。
CEC 临床评估小组5月18日, 2004年
医疗器械指令之上市后临床跟踪
前言：PMCF的基本原因和目标
本文件的目的是指为制造商和通告机构就如何执行PMCF, 和履行上市后监督义务提供指导性意见。参照医疗器械指令附录II 3. 1, 附录IV 3. 附录V 3, 附录VI 3.1 附录VII 4 (增加参阅AIMDD)。
虽然临床证据是上市前符合性评定程序的基本要素，但重要的是要认识到，这些上市前临床调查存在局限性。虽然在上市前阶段已经收集了广泛的数据，但是并不能保证制造商能够察觉到不常见的并发症或问题，而这些问题只有在医疗器械被大范围的使用和长期运行后才会显现。作为医疗器械制造商的质量体系，或上市后监督体系的一个部分，关键就是需识别和调查销售后的医疗器械在使用过程中所具有的风险。
制造商应建立上市后监督系统，并且对每一个产品或产品类都应有明确的PMS（上市后监督）策划。因此，选择PMCF(上市后临床跟踪)看起来是实现此目的的一个方法。通过建立一个长期的安全跟踪评审程序和侦查一些可能出现的风险，它可以使病人获得新的疗法，而这些风险仅仅依赖上市前的临床调查（仅仅要求相对很短的时间跟踪）和根据产品经验或产品警惕性都是不能完全充分地察觉到的。
医疗器械警戒系统指南-MEDDEV 2.12-1 REV.8 January 2013
Revision 8 of MEDDEV 2.12-1 explicitly includes IVF/ART devices within the scope of the vigilance system and provides clarity in relation to devices that are not intended to act directly on the individual. The revised guidance will be applicable as of July 2013.
1
MEDDEV 2 12-1 rev. 8 Vigilance
TABLE OF CONTENTS
TABLE OF CONTENTS ................................................................................................................................. 2 1 2 FOREWORD .................................................................................................................................... 4 INTRODUCTION .............................................................................................................................. 4
MEDDEV2.12.2rev2...
MEDDEV2.12.2rev2...
MEDDEV 2.12/2 rev2 January 2012
GUIDELINES ON MEDICAL DEVICES
POST MARKET CLINICAL FOLLOW-UP STUDIES
A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES 关于医疗设备指导方针药品上市后临床跟踪研究指导生产商和相关人员Note
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 interest parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts where circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interest parties in the medical devices sector. 注释
MEDDEV.中文版
欧盟委员会
企业和工业总署
日用消费品
化妆品和医疗器械
MEDDEV.2.7.1版本.3
2009年12月
医疗器械指南
临床评价:
制造商和公告机构指南
本指南为一系列与CE—医疗器械指令应用问题相关的指南中的一部分。并不具有法律约束力。该指南在经过与各个利益方（主管当局、服务委员会、行业委员会、其他利益相关团体）进行深入协商之后谨慎拟定而成，期间对中期草案进行了传阅，而且部分意见还为本文件所采纳。因此，本文件反映出了来自医疗器械行业的利益团体代表所持的立场。
本指南包含了指令2007/47/EC，90/385/EEC和93/42/EEC中的变更，并从2010年3月21日开始实施。2010年3月21日前的过渡时期应逐步地实施该指南。
注:
本文件是MEDDEV2.7.103年4月版的修订版。
本文件是在2007年6月29日发表在上的GHTF指南SG5/N2R8:2007临床评价的基础上起草的。
目录
前言........................................................................... . (4)
1.0引言........................................................................... . (5)
2.0范围........................................................................... .. (6)
3.0参考文献........................................................................... (7)
医疗器械产品的上市后临床跟踪
6.0 REFERENCES 相关文件 6.1 上市后临床跟踪计划
当在 93/42/EEC 指令中的框架下对生产商的质量体系进行符合性评估时，公告机构将审查生产商总体的 上市后监管程序和计划的适当性，包括 PMCF 计划及相关。
公告机构将核实作为 PMCF 计划一部分的临床调查是否按照附件 10（按照 93/42/EEC 第 15.8 条）的相关 规定、相关指导和相关标准。 5.7 文件及记录管理
5.3 上市后临床跟踪研究的要求
5.3.1 上市后临床跟踪研究是根据使用说明，在产品的预期用途/目的范围内执行；
上市后临床跟踪研究必须依据欧盟的法律和规章，遵循合适的指导和标准来进行。
5.3.2 上市后临床跟踪研究调查计划应包括但不限于：
·明确陈述的研究问题，目标和相关终结点。
·拥有适当的基本原理和统计分析计划的科学合理的设计。
度测量
每年一次
对顾客投诉进行相关的跟踪
质管部/市场部 当发生了顾客投诉时
对召回的产品进行深入关注
市场部/质管部 当实施了产品召回时
产品相关新标准/法规的研究
质管部/技术部 当产品相关标准有更新时
MEDDEV 2.12-2 rev2 2012 PMS
EUROPEAN COMMISSION
DIRECTORATE GENERAL for HEALTH and CONSUMERS
Consumer Affairs
Health technology and Cosmetics
Note
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 interest parties (competent authorities, Commission services, industries, other interested parties) during which intermediate drafts where circulated and comments were taken up in the document. Therefore, this document reflects positions taken by representatives of interest parties in the medical devices sector.
上市后临床跟踪控制程序
上市后临床跟踪控制程序
（ISO13485-2016）
1.0 PURPOSE
The purpose of this work instruction is to define the process to determine and document whether a post-market clinical follow-up study is required forTDI Foot/Ankle Array 8ch medical devices bearing the CE mark. The process will lead to a determination of whether a post-market clinical follow-up study is required and provide guidance for post-market clinical monitoring requirements if a study is not required.
2.0 SCOPE
The work instruction applies to all medical device businesses and sites operating under the TDI Foot/Ankle Array 8ch Healthcare Quality Management System.
Only medical devices bearing the CE Mark will be required to follow this work instruction.
上市后临床跟踪管理程序
1.PURPOSE
The purpose of this work instruction is to define the process to determine and
document whether a post-market clinical follow-up study is required forTDI
Foot/Ankle Array 8ch medical devices bearing the CE mark。The process will lead to a determination of whether a post-market clinical follow—up study is required
and provide guidance for post—market clinical monitoring requirements if a study is not required。
2.SCOPE
The work instruction applies to all medical device businesses and sites operating
under the TDI Foot/Ankle Array 8ch Healthcare Quality Management System.
Only medical devices bearing the CE Mark will be required to follow this work
MEDDEV2-122rev2
EUROPEAN COMMISSION
DIRECTORATE GENERAL for HEALTH and CONSUMERS
Consumer Affairs
Health technology and Cosmetics
MEDDEV 2.12/2 rev2
January 2012 GUIDELINES ON MEDICAL DEVICES
POST MARKET CLINICAL FOLLOW-UP STUDIES
A GUIDE FOR MANUFACTURERS AND NOTIFIED BODIES
Note
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 interest parties (competent authorities, Commission services, industries,
other interested parties) during which intermediate drafts where circulated and
欧盟MDR临床评价和上市后临床跟踪
欧盟MDR临床评价和上市后临床跟踪
欧盟MDR（Medical Device Regulation）是一项新的医疗器械法规，在2024年5月26日正式实施。MDR为欧盟成员国监管机构提供了更为严
格的要求，旨在确保医疗器械的安全性和有效性，并提高对患者的保护。
其中包括MDR对临床评价和上市后临床跟踪的规定。
首先，MDR对临床评价提出了更为严格的要求。根据新法规，制造商
需要进行一系列的临床评价来证明其产品的安全性和有效性。临床评价应
基于最新的医学和科学知识，并遵循科学方法和伦理原则。此外，评价还
应评估产品与患者的兼容性，以及产品在实际使用中的性能和效果。
临床评价的核心是临床试验，这是一项研究设计，旨在评估医疗器械
在患者身上的安全性和有效性。根据MDR的要求，试验应以符合道德要求
的方式进行，并采取必要的措施保护参与者的权益。此外，试验结果应具
有科学和统计学的可信性，并进行详细的数据分析和结果报告。
除了临床评价，MDR还要求制造商进行上市后的临床跟踪。这意味着
一旦产品获得市场准入，制造商需要跟踪产品在实际使用中的性能和安全性，并及时收集和分析相关数据。制造商还应与患者、医生和其他相关利
益相关方进行沟通，以了解产品在实际使用中的效果和问题，并采取相应
的改进措施。
总之，欧盟MDR对临床评价和上市后临床跟踪提出了更为严格的要求。制造商需要进行临床评价以证明产品的安全性和有效性，并使用科学方法
和伦理原则进行临床试验。同时，制造商还需要进行上市后的临床跟踪，
及时收集和分析相关数据，并与相关利益相关者进行沟通和合作。这些规
MEDDEV 2.12-2 医疗器械上市后临床跟踪指南
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.
上市后临床跟踪管理程序
1.PURPOSE
The purpose of this work instruction is to define the process to determine and
document whether a post-market clinical follow-up study is required forTDI
Foot/Ankle Array 8ch medical devices bearing the CE mark. The process will lead
to a determination of whether a post-market clinical follow-up study is required and provide guidance for post-market clinical monitoring requirements if a study is not
required.
2.SCOPE
The work instruction applies to all medical device businesses and sites operating
under the TDI Foot/Ankle Array 8ch Healthcare Quality Management System.
Only medical devices bearing the CE Mark will be required to follow this work
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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 manufacturer’s 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戒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 :