首页 > GHTF标准 > IMDRF MDCE WG/N65

IMDRF MDCE WG/N65FINAL:2021 Post-Market Clinical Follow-Up Studies - PDF (132kb)

赵静曼 4/18/2022 浏览 442 IMDRF MDCE WG/N65 全球范围

标准简介

Post-Market Clinical Follow-Up Studies - PDF (132kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group发布的GHTF标准，适用于全球范围。

标准截图

Post-Market Clinical Follow-Up Studies - PDF (132kb)[附网盘链接]
Post-Market Clinical Follow-Up Studies - PDF (132kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Post-Market Clinical Follow-Up Studies - PDF (132kb)[附网盘链接]高清PDF版本（文字版），标准文档内可进行搜索，可以复制原文，可粘贴。

标准部分原文

1.0 Introduction

While clinical evidence is an essential element of the premarket conformity

assessment process to demonstrate conformity to Essential Principles, it is important

to recognise that there may be limitations in the clinical data available in the

premarket phase. Such limitations may be due to, for example, the duration of

premarket clinical investigations, the number of subjects and the study sites involved

in an investigation, the relative homogeneity of subjects and investigators and the

control of variables in the setting of a clinical investigation versus use in the full range

of conditions encountered in routine use. Also, for some devices based on

scientifically well-established technologies, it may be important to recognise that

there may be limitations in the applicability of clinical data from comparable devices

to the device in question.

It is appropriate to place a product on the market once conformity to the relevant

Essential Principles, including a favorable benefit and risk, has been demonstrated.

Complete characterization of all potential risks and benefits may not always be

possible or practicable in the premarket phase. Therefore, there may be uncertainties

(such as rare adverse events, potential benefits, long-term safety, clinical performance

and/or effectiveness) that should be addressed in the post-market phase using one or

more systematic post-market clinical follow-up (PMCF) studies. PMCF studies are

not intended to replace the premarket data necessary for marketing authorization.

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

program and contribute to the risk management process.

2.0 Scope

This document is intended to provide guidance on the design, implementation and

appropriate use of PMCF studies.

This document provides guidance in relation to:

i) the circumstances where a PMCF study is indicated;

ii) the objectives of PMCF Studies;

iii) the design and implementation of PMCF studies; and

18 February, 2021 Page 4 of 17

网盘链接

百度网盘：https://pan.baidu.com/s/1AcFIuaIlPGW6sz_YiDUxww
提取码：aidn

【温馨提示】大资料ISO是提供信息发布的专业信息类网站，所有内容均由用户发布，不代表本站观点，本站亦不存储所涉及的文件及资料。如有【免费资料】以及【付费资料】,请用户根据自己的需求，自行判断是否需要获取。如有交易诈骗、内容侵权可发送邮件至kf@dzl100.com，我们审查后若发现情况属实，会立即对相关内容进行删除处理。

加载用时：57.6881 毫秒

相关评论

相关文章