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IMDRF MDCE WG/N57FINAL:2019 (formerly GHTF/SG5/N3:2010) Clinical Investigation - PDF (267kb)

赵静曼 9/28/2021 浏览 628 IMDRF MDCE WG/N57 全球范围

标准简介

Clinical Investigation - PDF (267kb)[附网盘链接]是Medical Device Clinical Evaluation Working Group于10 October 2019发布的GHTF标准，适用于全球范围。

标准截图

Clinical Investigation - PDF (267kb)[附网盘链接]
Clinical Investigation - PDF (267kb)[附网盘链接](截图)

 

标准文档说明

标准文档类型为Clinical Investigation - PDF (267kb)[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 February, 2010 (GHTF/SG5/N3:2010).

What is a clinical investigation?

A clinical investigation is defined as any systematic investigation or study in or on one or more

human subjects, undertaken to assess the safety, clinical performance and/or effectiveness of a

medical device.

The undertaking of a clinical investigation is a scientific process that represents one method of

generating clinical data.

What is the objective of a clinical investigation?

The objective of a clinical investigation is to assess the safety, clinical performance and/or

effectiveness of a medical device for a particular indication or intended use.

How is a clinical investigation conducted?

ISO 14155: 2011 Clinical Investigation of Medical Devices for Human Subjects — Good clinical

practice details the requirements for the conduct of clinical investigations. Clinical investigations

must take into account scientific principles underlying the collection of clinical data along with

accepted ethical standards surrounding the use of human subjects.

2.0 Scope

The primary purpose of this document is to provide guidance in relation to:

· when a clinical investigation should be undertaken for a medical device to demonstrate

compliance with the relevant Essential Principles (see IMDRF/GRRP WG/N47 FINAL:2018

“Essential Principles of Safety and Performance of Medical Devices and IVD Medical

Devices”); and

· the general principles of clinical investigation involving medical devices.

Given the wide diversity of medical devices and their associated risks, this document is not

intended to provide comprehensive guidance for clinical investigations of specific medical

devices.

The guidance contained within this document is intended to apply to medical devices other than

IVDDs. Additionally, this document was drafted primarily to address the use of Clinical

Investigations to support a marketing authorization application. Some aspects of this document

may apply to studies conducted following commercial release of a medical device. The GHTF

/SG5/N4:2010 – Post-Market Clinical Follow-Up Studies document specifically addresses post-

market clinical follow-up studies.

October 10, 2019 Page 4 of 11

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