MEDDEV 2.12.2rev2Post Market Clinical Follow-up studies上市后临床跟踪中英文

MEDDEV 2.12.2rev2Post Market Clinical Follow-up studies上市后临床跟踪中英文

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

本准则是有关欧共体指令对医疗器械的应用问题指引的一部分。其在法律上不具约束力。该指引通过对利益相关方（主管机构，委员会服务机构，行业人员，其他利益相关各方）进行详尽征询后审慎起草的。期间，中期草案经传阅，相关建议也收录在文档中。因此，该文件体现了医疗器械各相关方代表的立场。

CONTENTS

Introduction

Scope

References

Definitions

Circumstances where a post market clinical follow up study in indicated Elements of a post-market clinical follow up study

The use of study data

The role of the notified body in post-market clinical follow up 目录

介绍

范围

参考文献

定义

上市后临床跟踪研究所指环境

上市后临床跟踪研究原理

研究数据的用法

上市后临床跟踪中相关各方的作用

Preface

This document is intended to be a guide for manufacturers and Notified Bodies on how to carry out Post-Market Clinical Follow-up (PMCF) studies in order to fulfil Post-Market Surveillance (PMS) obligations according to Section 3.1 of Annex II, Section 3 of Annex IV, Section 3 of Annex V, Section 3.1 of Annex VI or Section 4 of Annex VII of the Medical Devices Directive (93/42/EEC) and Section 3.1 of Annex 2, Section 3 of Annex 4, Section 3.1 of Annex 5 of the Active Implantable Medical Devices Directive (90/385/EEC). These Sections refer to requirements of Annex X of Directive 93/42/EEC and Annex 7 of Directive 90/385/EEC, respectively. 前言

本文件旨在为生产商和相关各方提供指导，指导如何开展上市后的临床跟踪(PMCF)研究，以履行医疗器械指令（93/42/EEC）附录Ⅱ3.1,附录Ⅳ3，附录Ⅴ3，附录Ⅵ3.1或附录Ⅶ4和有源植入医疗器械指令（90/385/EEC）附录2.3.1，附录4.3，附录5.3.1中所要求的上市后市场监督(PMS)义务。这些部分分别是指令93/42/EEC附录ⅹ和指令90/385/EEC指令附录7所指要求。

Attention is drawn to paragraph 8 of Article 15 of Directive 93/42/EEC which spells out the provisions of Article 15 that are not applicable to clinical investigations conducted 提请注意指令93/42/EEC的第15条第8款，其阐述了第15条规定并不适用于CE标志器械用途范围内所进行的临床研究。

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using CE-marked devices within their intended use. Similarly when PMCF studies are conducted using CE marked devices within their intended use, the provisions of section 2.3.5 of Annex X of Directive 93/42/EEC do not apply. However, the provisions of Directive 93/42/EEC concerning information and notification of incidents occurring following placing devices on the market are fully applicable. 同样，在CE标志器械用途范围内进行PMCF研究时，指令93/42/EEC 附录ⅹ第2.3.5条的规定也不适用。然而，指令93/42/EEC的条款关于在市场上放置以下设备出现的事件信息和通知是完全适用的。

1. Introduction

While clinical evidence is an essential element of the premarket conformity assessment process to demonstrate conformity to Essential Requirements, it is important to recognise that there may be limitations to the clinical data available in the pre-market phase. Such limitations may be due to the duration of pre-market clinical investigations, the number of subjects and investigators involved in an investigation, the relative heterogeneity of subjects and investigators and/or the controlled setting of a clinical investigation versus the full range of clinical conditions encountered in general medical practice. 1介绍

虽然临床证据是上市前合格评定程序的基本要素，以证实符合基本要求，但是重要的是认识到在上市前阶段现有的临床数据可能存在局限性。这种局限性可能是由于上市前临床调查的期限、涉及到调查的主题和人员数量、主题和人员相对差异性和/或者在一般医疗实践中遇到的临床调查与全方位临床条件的控制设置所引起的。

A precondition for placing a product on the market is that conformity to the relevant Essential Requirements, including a favourable benefit/risk ratio, has been demonstrated. The extent of the data that can be gathered in the pre-market phase does not necessarily enable the manufacturer to detect rare complications or problems that only become apparent after wide-spread or long term use of the device. As part of the manufacturer’s quality system, an appropriate post-market surveillance plan is key to identifying and investigating residual risks associated with the use of medical devices placed on the market. These residual risks should be investigated and assessed in the post-market phase through systematic Post-Market Clinical Follow-up (PMCF) study(ies). 在市场上放置一种产品的先决条件是符合相关基本要求，其中包括一个合适的利益/风险比，这一观点已被证实。器械经广泛和长期应用后，上市前阶段收集的数据也并不一定能让生产商可以检测出罕见的并发症或是仅有在经过长期使用后才呈现的问题。作为生产商质量体系的一部分，一个合适的上市后监测程序的关键是识别和调查与投放市场的医疗器械应用相关的残余风险。这些残余风险应该在上市后阶段通过系统的上市后临床跟踪研究进行调查和评估。

Clinical data obtained from post-market surveillance and during PMCF studies by the manufacturer are not intended to replace the pre-market data necessary to demonstrate conformity with the provisions of the legislation. However, they are critical to update the clinical evaluation throughout the life-cycle of the medical device and to ensure the long term safety and performance of devices after their placing on the market. 生产商在上市后监察和上市后临床跟踪研究中获得的临床数据并不能替代必要的上市前数据，其用来证实有关法例的规定。然而，关键是更新医疗器械的整个生命周期的临床评价并确保投放于市场上后的器械长期安全性和性能性。

PMCF studies are one of several options available in post-market surveillance and

contribute to the risk management process.

上市后临床跟踪研究是上市后监察中几个可用选择之一，并有助于风险管理过程。

2. Scope

The objective of this document is to provide guidance on the appropriate use and conduct of PMCF studies to address issues linked to residual risks. The intention is not 2 范围

本文件的目的是提供恰当的使用指引和进行上市后临床跟踪研究，以解决相关残余风险的问题。并不旨在实施新的监管要求。

MEDDEV 2.12.2rev2Post Market Clinical Follow-up studies上市后临床跟踪中英文

to impose new regulatory requirements.

PMCF studies are an important element to be considered in PMCF or PMS plans. The principles for PMCF studies set out in this guidance are not intended to replace PMCF or PMS plans. They are or may be applicable to PMCF studies conducted for other purposes. PMCF研究是在PMCF或PMS计划中要考虑的一个重要因素。载列于本指引的PMCF 研究原则并不旨在取代PMCF或者PMS计划。它们是或者可以适用于其他目的进行的PMCF研究。

This document provides guidance in relation to:

i) the circumstances where a PMCF study is indicated;

ii) the general principles of PMCF studies involving medical devices;

iii) the use of study data (for example to update instructions for use and labelling); and

iv) the role of a notified body for medical devices in the assessment of PMCF plans and of the results obtained from the plans as part of conformity assessment.

This document does not apply to in vitro diagnostic devices. 本文件提供了相关指导：

PMCF研究表明的情况

关于医疗器械的PMCF研究的一般原则

研究数据的使用（例如更新使用和贴标签的说明）

在PMCF计划评估中的医疗器械指定机构和作为合格评定一部分的计划中得到的结果所起作用

此文件不适用体外诊断器械。

3. References

Council Directive 93/42/EEC of 14 June 1993 concerning medical devices as last amended by Directive 2007/47/EC of the European Parliament and of the Council of

5 September 2007.

Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices last amended by Directive 2007/47/EC of the European Parliament and of the Council of 5 September 2007. 3.参考文献

1993年6月14日关于医疗器械的理事会指令93/42/EEC 于2007年9月5日根据欧洲议会和理事会的指令2007/47/EC最后一次修正。

1990年6月20日关于有源植入医疗器械的成员国相似法案的理事会指令90/385/EEC,于2007年9月5日根据欧洲议会和理事会的指令2007/47/EC最后一次修正。

Interpretative Documents

MEDDEV 2.7.1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies MEDDEV 2.7.1, Appendix 1

Evaluation of Clinical Data – A Guide for Manufacturers and Notified Bodies – Appendix 1: Clinical Evaluation of Coronary Stents

GHTF Final Documents:

SG1/N41:2005 Essential Principles of Safety & Performance of Medical Devices

SG1/N44:2008 The Role of Standards in the Assessment of Medical Devices

SG1/N065:2010 Registration of Manufacturers and Other Parties and Listing of Medical Devices

SG2/N47:2005 Review of Current Requirements on Post-Market Surveillance

SG5/N1:2007 Clinical Evidence – Key Definitions and Concepts 解释性文件

MEDDEV2.7.1 临床评估：针对生产商和指定各方的指引

MEDDEV2.7.1，附录1

临床数据的评估-针对生产商和指定各方的指引-附录1：冠状动脉支架的临床评估GHTF最终文件：

SG1/N41：2005 医疗器械的安全性和有效性的基本原则

SC1/N44：2008 医疗器械标准评估的作用

SG1/N065：2010 生产商和其他各方以及所列医疗器械的注册

SG2/N47:2005 上市后监察的当前要求审查

SG5/N1：2007 临床证据-关键的定义和概念

SG5/N2：2007 临床评估

SG5/N3：2010 临床调查

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SG5/N2:2007 Clinical Evaluation SG5/N3:2010 Clinical Investigations

International Standards:

EN ISO 14155:2011 Clinical investigation of Medical Devices for human subjects Good clinical practice; Second edition 2011-02-01

EN ISO 14971:2009 Application of risk management to medical devices

Others:

US Department of Health and Human Service, Agency for Healthcare Research and Quality:

Registries for Evaluating Patient Outcomes: a User’s Guide (Executive Summary, April 2007). 国际标准：

EN ISO14155：2011 人类受试者的医疗器械临床调查良好的临床实践；2011-02-01第二版

EN ISO14971：2009 医疗器械的风险管理应用

其他：

健康和人类服务的美国部门，卫生保健研究和质量的机构：

注册评估患者治疗效果：使用者的指引（执行摘要，2007年4月）

4. Definitions

Clinical Data 1 :

The safety and/or performance information that is generated from the use of a device. Clinical data are sourced from:

- clinical investigation(s) of the device concerned; or

- clinical investigation(s) or other studies reported in the scientific literature

of a similar device for which equivalence to the device in question can be demonstrated; or

- published and/or unpublished reports on other clinical experience of either

the device in question or a similar device for which equivalence to the device in question can be demonstrated. 4定义

临床数据：

关于证明器械在临床使用时其安全性和/或有效性的信息。

临床数据来源于：

-有关器械的临床调查；或

-同类或等同产品的临床报告或科学文献中的其他研究报告；或者

-同样的器械或者同类器械的，发布的或者没有发布的，其他临床经验。

Clinical Evaluation 2 :

The assessment and analysis of clinical data pertaining to a medical device to verify the clinical safety and performance of the device when used as intended by the manufacturer. 临床评估：

关于医疗器械的临床数据评估和分析，在生产商使用该设备时用以验证临床安全性和有效性。

Clinical Evidence 2 :

The clinical data and the clinical evaluation report pertaining to a medical device. 临床证据：

关于医疗器械的临床数据和临床评估报告。

Clinical Investigation 2 :

Any systematic investigation or study in or on one or more human subjects, undertaken to assess the safety or performance of a medical device. 临床调查：

就一个或者多个受试者的任何系统化调查或者研究，旨在评估医疗器械的安全性或者有效性。

Device Registry 3 :

An organised system that uses observational study methods to collect defined clinical 器械注册：

一种有组织的体系，其使用观察研究方法以收集一个或多个设备在正常使用条件下

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data under normal conditions of use relating to one or more devices to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure and that serves predetermined scientific, clinical or policy purpose(s). Note: The term “device registry” as defined in this guidance should not be confused with the concept of device registration and listing. (See GHTF SG1N065) 确定的临床数据，以便评估已确认患有特定疾病、病症或曝光的种群的特定结果，并且其服务于预知科学，临床或者政策目标。

注释：本指引中定义的术语“器械注册”不应与器械注册和上市概念相混淆。（详见GHTF SG1N065）

Post-market clinical follow-up (PMCF) study:

A study carried out following the CE marking of a device and intended to answer specific questions relating to clinical safety or performance (i.e. residual risks) of a device when used in accordance with its approved labelling. 上市后临床跟踪研究：

该研究是器械CE标记后所开展的，并旨在回答关于器械临床安全性或者有效性（例如残余风险）的特定问题，已获批准贴标使用。

PMCF plan:

The documented, proactive, organised methods and procedures set up by the manufacturer to collect clinical data based on the use of a CE-marked device corresponding to a particular design dossier or on the use of a group of medical devices belonging to the same subcategory or generic device group as defined in Directive 93/42/EEC. The objective is to confirm clinical performance and safety throughout the expected lifetime of the medical device, the acceptability of identified risks and to detect emerging risks on the basis of factual evidence. PMCF计划：

由生产商记录的，前瞻性的有组织的方法和程序，以收集临床数据，该数据基于相应的特定设计档案来使用CE标记的器械，或者基于对属于同一子类别或通用器械组的医疗器械的使用，此在指令93/42/EEC有所规定。其目标是在医疗器械的整个预测有效期内验证临床有效性和安全性，已定风险的可接受性，同时基于事实证据来检测出现的风险。

Residual Risk:

Risk remaining after risk control measures has been taken . 残余风险：

已采取风险控制措施后的遗留风险。

5. Circumstances where a PMCF study is indicated

Following a proper premarket clinical evaluation, the decision to conduct PMCF studies must be based on the identification of possible residual risks and/or unclarity on long term clinical performance that may impact the benefit/risk ratio.

PMCF studies may review issues such as long-term performance and/or safety, the occurrence of clinical events (e.g. delayed hypersensitivity reactions, thrombosis), events specific to defined patient populations, or the performance and/or safety of the device in a more representative population of users and patients. 5.PMCF研究表明的情况

适当的上市前临床评估之后，开展PMCF研究的决定必须基于对可能残留风险的识别和/或不明确的可能影响利益/风险比的临床长期有效性。

PMCF研究会审查如长期有效性和/或安全性的问题，发生的临床事件（例如延迟性的过敏反应，血栓形成），限定患者群体的事件，或者在更具代表性的用户和或者使用器械的有效性和/安全性。

Circumstances that may justify PMCF studies include, for example:

innovation, e.g.

, where the design of the device, the materials, substances, the principles of operation, the technology or the medical indications are novel;

significant changes to the products or to

its intended use for which pre-market clinical evaluation and re-certification has been completed;

high product related risk e.g. based on design, materials, components , 可证明PMCF研究的情况包括，例如：

创新，例如，其中器械的设计，材料，物质，操作原理，技术或医学适应症是新的；显著变化，关于产品或者上市前临床评估和重新认证已完成后的用途；

产品的高相关危险，例如基于设计，材料，部件，侵入力，临床程序；

高风险的解剖位置；

高危目标人群如儿科，老年；

MEDDEV 2.12.2rev2Post Market Clinical Follow-up studies上市后临床跟踪中英文

invasiveness, clinical procedures;

h

igh risk anatomical locations;

high risk target populations e.g. paediatrics, elderly;

severity of

disease/treatment challenges;

questions of ability to generalise clinical investig

ation results;

unanswered questions of long

-term safety and performance;

results from any previous clinical investigation, including adverse events

or from post-market surveillance activities;

identification of previously unstudied

subpopulations which may show different benefit/risk-ratio e.g. hip implants in different ethnic populations;

continued validation in cases of discrepancy between reasonable

premarket follow-up time scales and the expected life of the product;

risks identified from the literature or other data sources for similar

marketed devices;

interaction with other medical products or treatments;

verification of safety and perform

ance of device when exposed to a larger and more varied population of clinical users;

emergence of new information on safety or performance;

where CE marking was based on equivalence.

重大疾病/治疗挑战；

临床调查结果归纳能力的问题；

长期安全性和有效性的未解问题；

来自之前的临床调查，包括不良事件或来自上市后监察活动的结果；

之前未研究可显示不同效益/风险比的亚群的识别，例如在不同种族人群的髋关节植入物；

持续验证关于合理的上市前跟踪时间跨度和产品的预测有效期之间的差异；

来自文献或类似上市器械的其他数据源的风险识别；

与其他医疗产品或者治疗方法的相互作用；

当器械暴露在更多和更多样性临床用户人群中时，安全性和有效性的验证；

关于安全性或有效性的新信息的出现；

基于同类的CE标记。

PMCF studies may not be required when the medium/long-term safety and clinical performance are already known from previous use of the device or where other appropriate post-market surveillance activities would provide sufficient data to address the risks. PMCF研究可以不需要，在从之前的器械应用中已得知中期/长期的安全性和临床有效性时，或者在其他合适的上市后监察活动提供了足够的数据来应对风险时。

6. Elements of a PMCF study

Post-market clinical follow-up studies are performed on a device within its intended use/purpose(s) according to the instructions for use. It is important to note that PMCF studies must be conducted according to applicable laws and regulations and should involve an appropriate methodology and follow appropriate guidance and standards. 6. PMCF研究原理

上市后临床跟踪研究是根据器械的使用说明，在其指定用途内进行的。重要的是，需注意PMCF研究必须根据可适用法律法规进行，并且应该包括一个适当的方法和遵循适当的指导、标准。

PMCF studies must be outlined as a well designed clinical investigation plan or study plan, and, as appropriate, include:

clearly

stated research question(s), objective(s) and related endpoints;

scientifically sound design with an appropriate rati

onale and statistical analysis plan;

a plan for conduct according to the appropriate standard(s); PMCF研究必须可概括和设计为临床调查计划或者研究计划，并适当包括：明确提出研究课题，目标和相关终点；

科学合理的设计，有合适的理由和统计分析计划；

根据相应标准进行的计划；

数据分析和得出相当结论的计划；

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a plan for an analysis of the data and for drawing appropriate conclusion(s).

Objectives of PMCF studies

The objective(s) of the study should be stated clearly and should address the residual risk(s) identified and be formulated to address one or more specific questions relating to the clinical safety or clinical performance of the device. A formal hypothesis should be clearly expressed. PMCF研究目标

该研究的目标应该明确阐明，并应解决确定的残余风险，同时系统化以解决关于器械临床安全性和临床有效性的一个或多个特定问题。正式的假设是清楚表达的。

Design of PMCF studies

PMCF studies should be designed to address the objective(s) of the study. The design may vary based on the objective(s), study hypothesis research question and endpoints and should be scientifically sound to allow for valid conclusions to be drawn. PMCF研究的设计

PMCF研究应该旨在解决该研究的目标。其设计可能会因目标、假设研究、问题研究和终点而多样性，同时其应该科学合理一遍得出有效结论。

PMCF studies can follow several methodologies, for example:

the extended follow

-up of patients enrolled in premarket investigations;

a new clinical investigation;

a review of data derived from a device registry; or

a review of relevant retrospective data from patients previously exposed to the device. PMCF研究可遵循几个方法，例如：

参加上市前调查的患者的长期跟踪研究；

一次新的临床调查；

从设备注册表中导出数据进行审查；或者

对来自之前接触过器械的患者的相关回顾性数据进行审查；

PMCF studies should have a plan describing the design and methodologies appropriate for addressing the stated objectives. The clinical investigation plan/study plan should identify and where needed justify at a minimum:

the study population (co

rresponding to the CE-mark scope);

inclusion/exclusion criteria;

rational and justification of the chosen study design including use of

controls/control groups (where relevant; randomised or not);

the selection of

sites and investigators;

study objectives and related study endpoints and statistical considerations;

the number of subjects involved;

the duration of patient follow

-up;

the data to be collected;

the analysis plan including any inte

rim reporting where appropriate to

ensure continuous risk management based on clinical data; and

procedures/criteria for early study termination;

ethical considerations;

methods of quality control of data where appropriate.

PMCF研究应该有一个描述适当设计方案和方法，以解决既定目标的计划。临床调查计划/研究计划应该明确并至少需要证明：

研究群体（相当于CE标志范围内）；

纳入/排除标准；

所选研究设计的理性和理由，包括控制/对照组的使用（相关；随机与否）；

站点和研究者的选择；

研究目标、相关的研究终点和统计方面的考虑；

所包含的目标数量；

随访患者的持续时间；

收集的数据；

分析计划包括任何中期报告，在适当情况下以确保根据临床数据进行持续的风险管理；和

早期研究终止的程序/标准；

伦理方面的考虑；

适当情况下，质量控制方法的数据。

上述各点并不全适用于回顾性数据审查。

MEDDEV 2.12.2rev2Post Market Clinical Follow-up studies上市后临床跟踪中英文

The points above may not all apply to a retrospective data review.

Implementation of the PMCF study, analysis of data and conclusion(s)

The study should:

be executed with adequate control measures to assure compliance with the

clinical investigation or study plan;

include data analysis with conclusions drawn according to the analysis plan by

someone with appropriate expertise; and have a final report with conclusions relating back to original objective(s) and hypothesis/hypotheses. PMCF研究的实施，数据分析和结论

该研究应该是：

执行适当的控制措施，以确保符合临床调查或者研究计划；

包括根据某人用适当的专业知识进行的分析计划而得出的结论的数据分析；和有一份结论的最终报告，涉及到原始的目标和假设/假说。

7. The use of study data

The data and conclusions derived from the PMCF study are used to provide clinical evidence for the clinical evaluation process. This may result in the need to reassess whether the device continues to comply with the Essential Requirements. Such assessment may result in corrective or preventive actions, for example changes to the labelling/instructions for use, changes to manufacturing processes, changes to the device design, or public health notifications. 7.研究数据的应用

从PMCF研究得出的数据和结论是用来在临床评估过程中提供临床证据的。这可能会导致需要重新评估设备是否仍然符合基本要求。这种评估可能会造成纠正或预防措施，例如更改标签/使用说明，更改生产过程，更改设备设计，或者公共卫生通知。

8 The role of the notified body in PMCF

When auditing the quality system of the manufacturer in the framework of one of the conformity assessment annexes of Directive 90/385/EEC or of Directive 93/42/EEC, the Notified Body (NB) shall review the appropriateness of the manufacturer’s general post-market surveillance procedures and plans, including plans for PMCF, as relevant. 8.PMCF中公告机构的作用

当在指令90/385/EEC或者指令93/42/EEC附录合格评定框架内，审核生产商的质量体系时，指定各方应审查生产商的整体上市后监察程序和计划，包括PMCF计划，相关的适当性。

The Notified Body shall verify that PMCF as part of the overall clinical evaluation is conducted by or on behalf of the manufacturer by appropriately competent assessors (as per section 10.3 of MEDDEV 2.7/1). 公告机构应确认作为整体临床评估一部分的PMCF是由或通过代表生产商的适当主管评估员进行的.（根据MEDDEV2.7/1节10.3）

The NB shall verify that clinical investigations conducted as part of PMCF plans are conducted in accordance with the relevant provisions of Annex X (as per Article 15.8 of 93/42/EEC), related guidance and relevant standards. 公告机构应确认以PMCF计划一部分实施的临床调查需依据附录X（依据93/42/EEC 中15.8条款）相关规定，相关指引和相关标准来进行。

The NB shall as part of its assessment of a specific medical device 5 :

verify that the manufacturer has appropriately consider

ed the need for PMCF as part of post market surveillance based on the residual risks including those identified from the results of the clinical evaluation and from the characteristics of the medical device in accordance with section of the guidance;

verify that PMCF is conducted when clinical evaluation was based

exclusively on clinical data from equivalent devices for initial conformity assessment and that PMCF 作为特定医疗器械评估中的一部分，公告机构需：

确认生产商已适当考虑到作为上市后监察一部分的PMCF需求，这基于来自临床评估结果和医疗器械特性的那些特定残余风险，符合该指引第5部分；

确认在临床评估是仅基于来自同类产品最初的合格评定的临床数据和PMCF解决同类产品确认的残余风险时，进行PMCF;

评估由生产商提供的任何理由的适当性，不进行作为上市后监察一部分的特定PMCF 计划，并在理由无效时寻求适当的补救措施；

MEDDEV 2.12.2rev2Post Market Clinical Follow-up studies上市后临床跟踪中英文

addresses the residual risks identified for the equivalent devices;

assess the appropriateness of any justification presented by a manufacturer

for not conducting a specific PMCF plan as part of post market surveillance and seek appropriate remedy where the justification is not valid;

assess the appropriateness of the proposed PMCF plan in demonstrating the

manufacturer’s stated objectives and addressing the residual risks and issues of long term clinical performance and safety identified for the specific device;

verify that data gathered by the manufacturer from PMCF, whether favourable or unfavourable, is being used to actively update the clinical evaluation (as well as the risk management system);

consider whether, based on the specific device a

ssessment, data obtained from PMCF should be transmitted to the NB between scheduled assessment activities (e.g. surveillance audit, recertification assessment);

consider an appropriate period fo

r certification of the product in order to set a particular time point at which PMCF data will be assessed by the NB or specific conditions relating to certification for subsequent follow up. (This decision may be based on the residual risks, the characteristics presented in section 5 and the clinical evaluation presented at the time of initial assessment. Conditions the NB may consider could include the need for the manufacturer to submit interim reports between certification reviews, of the clinical data generated from the PMCF and post-market surveillance system). 评估所提PMCF计划在表明生产商既定目标和解决剩余风险及对特地设备长期临床有效性、安全性的已定问题时的恰当性；

确认由生产商从PMCF收集的数据，无论有利或不利，正被用于积极更新临床评估（以及风险管理体系）；

考虑在特定设备评估条件下，是否从PMCF获得的数据应该在预定的评估活动之间传送到公告机构（例如监督社会，换证考核）；

考虑产品认证的恰当时间，以便可以设置一个特定时间点，那时PMCF数据可以由公告机构或有关认证后续跟进的特殊条件来进行评估（这一决定可基于残余风险，章节5呈现的特性和在初步评估时间段呈现的临床评估。公告机构可考虑的条件可能包括生产商的需求，以提交认证审核的中期报告，从PMCF和上市后监察体系产生的临床数据）。

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