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GHTF/SG5/N6:2012 GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012 - PDF (311kb)

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标准简介

GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012 - PDF (311kb)[附网盘链接]是于November 2 , 2012发布的GHTF标准，适用于全球。

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GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012 - PDF (311kb)[附网盘链接]
GHTF SG5 Clinical Evidence for IVD Medical Devices - November 2012 - PDF (311kb)[附网盘链接](截图)

 

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标准部分原文

Study Group 5 Final Document GHTF/SG5/N6:2012

1.0 Introduction

GHTF would seek to evolve beyond convergence of regulatory requirements to embrace mutual

acceptance of common data submissions, pre-market conformity assessment processes, quality

systems, quality systems auditing results, and a broad sharing of post-marketing experience. The

objective was to allow presentation of data that are acceptable in principle to relevant authorities

as the basis for meeting regulatory requirements.

The broad goal for Study Group 5 is to promote the convergence of the regulatory requirements

for the generation and presentation of evidence of the clinical safety and performance of medical

devices. The Study Group 5 document SG5/N1R8 recognizes that, in order to progress

convergence of regulatory requirements and acceptance of common data, it is necessary to have

a common understanding and application of terminology, concepts and principles.

Taking into account the differences between IVD medical devices and other medical devices it

was considered necessary to develop a document to specifically address the concepts, principles

and terminology for clinical evidence related to IVD medical devices.

It is anticipated that convergence of requirements for clinical evidence, including common data

submissions, will lead to better understanding of an IVD medical device’s scientific validity and

performance by all stakeholders, more efficient use of resources of the clinical community,

medical device regulators and industry, and increased transparency and confidence in the global

regulatory model. Ultimately, there should be more efficient, predictable and timely access to

IVD medical devices by patients and society worldwide.

When placing an IVD medical device on the market the manufacturer must have demonstrated

through the use of appropriate conformity assessment procedures that the device complies with

the GHTF’s Essential Principles of Safety and Performance of Medical Devices (EPs).

Generally, from a clinical evidence perspective, it is expected that the manufacturer has

demonstrated the device achieves its intended performance during normal conditions of use in

the intended environment (e.g. laboratories, physician’s offices, healthcare centers, home

environments) and in the intended use population. As IVD medical devices are used for the

examination of specimens derived from the human body, the characteristics of clinical evidence

are different from medical devices other than IVD medical devices.

2.0 Scope

This document is intended to:

 introduce the concepts and definitions of clinical evidence for IVD medical devices;

 examine the relationship between clinical evidence (scientific validity, analytical

performance and, where applicable, clinical performance) and clinical utility;

nd

November 2 , 2012 Page 4 of 11

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