CONTENTS
Preface (3)
1.0 Introduction (4)
2.0 Scope (5)
3.0 References (6)
4.0 Definitions (6)
5.0 General principles of clinical evaluation (8)
6.0 Sources of data/documentation used in a clinical evaluation (Stage 1) (12)
6.1 Data generated through literature searching 12
6.2 Data generated through clinical experience 13
6.3 Data from clinical investigations 15
7.0 Appraisal of clinical data (Stage 2) (16)
8.0 Analysis of the clinical data (Stage 3) (17)
9.0 The Clinical Evaluation Report (18)
Appendices (19)
Preface
The document herein was produced by the Global Harmonization Task Force, a voluntary group of representatives from medical device regulatory agencies and the regulated industry.  The document is intended to provide non-binding guidance for use in the regulation of medical devices, and has been subject to consultation throughout its development.
There are no restrictions on the reproduction, distribution or use of this document; however, incorporation of this document, in part or in whole, into any other document, or its translation into languages other than English, does not convey or represent an endorsement of any kind by the Global Harmonization Task Force.
1Introduction
What is clinical evaluation?
Clinical evaluation is the assessment and analysis of clinical data pertaining to a medical device in order to verify the clinical safety and performance of the device.
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 conformity assessment process leading to the marketing of a medical device and then repeated periodically as new clinical safety and performance information about the device is obtained during its use.  This information is fed into the ongoing risk analysis and may result in changes to the Instructions for Use.
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 device complies with the Essential Principles of Safety and Performance of Medical Devices (the Essential Principles).  Generally, from a clinical perspective, it is expected that the manufacturer has demonstrated the device achieves its inte
documented evidence
nded performance during normal conditions of use and that the known, and foreseeable risks, and any adverse events, are minimised and acceptable when weighed against the benefits of the intended performance, and that any claims made about the device’s performance and safety (e.g. product labelling and instructions for use) are supported by suitable evidence.
With regard to post market activities, manufacturers are expected to implement and maintain surveillance programs that routinely monitor the clinical performance and safety of the device as part of their Quality Management System.  The scope and nature of such post market surveillance should be appropriate to the 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 and formal post market surveillance studies; etc), a manufacturer should periodically review performance, safety and the benefit-risk assessment for the 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 device or that would indicate a need for labelling changes regarding contraindications, warnings, precautions or instructions for use etc.
What is the process?
To conduct a clinical evaluation, a manufacturer needs to:
•identify the Essential Principles that require support from relevant clinical data;
•identify available clinical data relevant to the device and its intended use;
•evaluate data in terms of its suitability for establishing the safety and performance of the device;
•generate any clinical data needed to address outstanding issues;
•bring all the clinical data together to reach conclusions about the clinical safety and performance of the device.
The results of this process are documented in a clinical evaluation report.  The clinical evaluation report and the clinical data on which it is based serve as the clinical evidence that supports the marketing of the device.
The clinical evidence, along with other design verification and validation documentation, device descrip
tion, labelling, risk analysis and manufacturing information, is needed to allow a manufacturer to demonstrate conformity with the Essential Principles and is part of the technical documentation of a medical device.
How detailed should the clinical evaluation be?
A clinical evaluation should be thorough and objective (i.e it should consider both favourable and unfavourable data), with the intention of demonstrating valid clinical evidence of the safety and performance of the device.  However, it is important to recognise that there is considerable diversity in the types and history of technologies used in medical devices and the risks posed by them.  Many devices are developed or modified by incremental innovation, so they are not completely novel.  Thus, it is often possible to draw on the clinical experience and literature reports of the safety and performance of comparable devices to establish the clinical evidence, thereby reducing the need for clinical data generated through clinical investigation of the device in question.  Similarly, it may be possible to use compliance with recognised standards to satisfy the clinical evidence requirements for devices based on technologies with well established safety and performance characteristics.
The depth and extent of clinical evaluations should be flexible, not unduly burdensome, and appropriat
e to the nature, intended use and risks of the device in question.  Therefore, this guidance is not intended to impose specific requirements.
2Scope
The primary purpose of this document is to provide manufacturers with guidance on how to conduct and document the clinical evaluation of a medical device as part of the conformity assessment procedure prior to placing a medical device on the market as well as to support its ongoing marketing.  It is also intended to provide guidance to regulators and other stakeholders when assessing clinical evidence provided by manufacturers.
This document provides the following guidance:
•general principles of clinical evaluation;
•how to identify relevant clinical data to be used in a clinical evaluation;
•how to appraise and integrate clinical data into a summary; and

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