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GHTF/SG5/N8:2012 GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012 - PDF (419kb)

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GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012 - PDF (419kb)[附网盘链接]由Study Group 5 of the Global Harmonization Task Force于November 2 , 2012发布，适用于世界。

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GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012 - PDF (419kb)[附网盘链接]
GHTF SG5 Clinical Performance Studies for IVD Medical Devices - November 2012 - PDF (419kb)[附网盘链接](截图)

 

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Study Group 5 Final Document GHTF/SG5/N8:2012

1.0 Introduction

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

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

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

IVD medical device achieves its intended performance during normal conditions of use by the

intended user in the intended environment (e.g. laboratories, physician’s offices, healthcare

centers, home environments) and in the intended use population.

The objective of a clinical performance study is to evaluate whether the IVD medical device is

suitable (i.e. meets the relevant Essential Principles of Safety and Performance) for the

purpose(s) and the population(s) for which it is intended, when this cannot be addressed with the

analytical performance data, literature and/or experience gained by routine diagnostic testing.

In general, clinical performance studies must be designed according to, and take into account

scientific principles underlying the collection of clinical performance data along with accepted

operational and ethical standards surrounding the use of human subjects. The clinical

performance study objectives and design should be documented in a clinical performance study

protocol. The data collection process must ensure patient safety and data integrity along the

entire process of the study.

2.0 Scope

The primary purpose of this document is to provide guidance for manufacturers of IVD medical

devices, Regulatory Authorities (RA) and Conformity Assessment Bodies (CAB) in relation to:

 the selection of a clinical performance study design

 considerations to be made when undertaking a clinical performance study; and

 protocol, conduct and report of a clinical performance study

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

intended to provide comprehensive guidance for clinical performance studies of specific IVD

medical devices.

Clinical performance studies are typically performed in the pre-market phase. However, this

document may also apply to studies conducted in the post-market phase.

NOTE: This document should not be used in isolation but read together with the documents

‘Clinical evidence for IVD medical devices – Key Definitions and Concepts’ and

‘Clinical evidence for IVD medical devices – Scientific Validity Determination and

Performance Evaluation’ as well as the document ‘Essential Principles of Safety and

nd

November 2 , 2012 Page 4 of 21

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