首页 > GHTF标准 > llVIUfir Device Regulators Forum

l l V I U f i r Device Regulators Forum Clinical Evaluation - PDF (322kb)

赵静曼 9/28/2021 浏览 288 llVIUfir Device Regulators Forum 全球

标准简介

Clinical Evaluation - PDF (322kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group于10 October 2019发布的GHTF标准，适用于全球。

标准截图

Clinical Evaluation - PDF (322kb)[附网盘链接]
Clinical Evaluation - PDF (322kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Clinical Evaluation - PDF (322kb)[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

This document supersedes an earlier version produced under the Global Harmonization Task

Force (GHTF) with the same title in May, 2007(GHTF/SG5/N2R8:2007).

What is clinical evaluation?

Clinical evaluation is a set of ongoing activities that use scientifically sound methods for the

assessment and analysis of clinical data to verify the safety, clinical performance and/or

effectiveness of the medical device when used as intended by the manufacturer.

When is clinical evaluation undertaken?

Clinical evaluation is an ongoing process conducted throughout the life cycle of a medical

device. It is first performed during the development of a medical device in order to identify data

that need to be generated for regulatory purposes and will inform if a new device clinical

investigation is necessary, together with the outcomes which need to be studied. It is then

repeated periodically as new safety, clinical performance and/or effectiveness information about

the medical device is obtained during its use. This information is fed into the ongoing risk

management process (according to ISO 14971:2007) and may result in changes to the

manufacturer's risk assessment, clinical investigation documents, Instructions for Use and post

market activities.

Why is clinical evaluation important?

When placing a medical device on the market, the manufacturer must have demonstrated

through the use of appropriate conformity assessment procedures that the medical device

complies with the Essential Principles of Safety and Performance of Medical Devices (the

Essential Principles). Generally, it is expected that the manufacturer has demonstrated the

medical device achieves its intended performance during use according to its labelling (i.e.

information supplied by the manufacturer) and that the known and foreseeable risks are

minimised and acceptable when weighed against the benefits. Any claims made about the

medical device’s safety, clinical performance and/or effectiveness should be supported by

suitable evidence.

With regard to post market activities, manufacturers are expected to implement and maintain

surveillance programs that routinely monitor the safety, clinical performance and/or effectiveness

of the medical device as part of their Quality Management System. The scope and nature of

such post market surveillance should be appropriate to the medical device and its intended use.

Using data generated from such programs (e.g. safety reports, including adverse event reports;

results from published literature, any further clinical investigations), a manufacturer should

periodically review performance, safety and the benefit-risk assessment for the medical device

through a clinical evaluation, and update the clinical evidence accordingly. This ongoing

clinical evaluation process should allow manufacturers to communicate with conformity

assessment bodies and regulatory authorities in accordance with local reporting requirements any

information that has an important bearing on the benefit-risk assessment of the medical device or

网盘链接

百度网盘：https://pan.baidu.com/s/1Myr4zN6esQp_vr5UhmGjAA
提取码：pc75

【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：43.5576 毫秒

相关评论

相关文章