MEDDEV2.122上市后临床跟踪指南中英文对照版

EUROPEAN COMMISSION

DG ENTERPRISE

Directorate G

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 app ropriate 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