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IMDRF MDCE WG/N55 FINAL:2019 (formerly GHTF/SG5/N1R8:2007) Clinical Evidence - Key Definitions and Concepts - PDF (185kb)

赵静曼 10/5/2021 浏览 427 IMDRF MDCE WG/N55 世界

标准简介

Clinical Evidence - Key Definitions and Concepts - PDF (185kb)[附网盘链接]由Medical Device Clinical Evaluation Working Group于10 October 2019发布，适用于世界。

标准截图

Clinical Evidence - Key Definitions and Concepts - PDF (185kb)[附网盘链接]
Clinical Evidence - Key Definitions and Concepts - PDF (185kb)[附网盘链接](截图)

 

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标准部分原文

1.0 Introduction

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

1

Force (GHTF) with the same title in May, 2007(GHTF/SG5/N1R8:2007).

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

submissions, will lead to better understanding of medical device safety, clinical performance

and/or effectiveness 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 safe and effective medical technology by patients and society worldwide.

Clinical evidence and the Essential Principles of safety and performance of medical devices

The IMDRF Essential Principles of Safety and Performance of Medical Devices and IVD

Medical Devices (the Essential Principles) set out the requirements relating to the safety and

performance of medical devices. Of these, Essential Principles 5.1.1, 5.1.6, 5.1.7 and 5.1.9 in

particular require that a medical device achieve its intended performance during use according to

its labelling and that the known, and foreseeable risks, and any undesirable side-effects, are

minimised and acceptable when weighed against the benefits of the intended performance.

The diversity of medical devices and the technologies on which they are based pose special

challenges for manufacturers, conformity assessment bodies and regulators alike when trying to

identify what should constitute evidence sufficient to demonstrate compliance with the Essential

Principles. Some technologies have been available for many years and are well characterised

from a safety, clinical performance and/or effectiveness viewpoint. On the other hand, many

medical devices utilise new, state-of-the-art technology that has had little prior application in

the treatment of humans.

Furthermore, their intended purpose and clinical application can vary widely with end results

influenced by a wide range of different and differently experienced end-users.

Given the complexity of the medical devices milieu, the assessment of what is acceptable clinical

evidence for the purpose of demonstrating compliance with the Essential Principles must be

undertaken on a case-by-case basis. To this end, it is important to have an understanding of how

medical devices are brought to market and of the role that clinical data and its evaluation plays in

this process.

2.0 Scope

This document is intended to:

· introduce the concepts of clinical evaluation and clinical evidence;

· examine the relationship between clinical investigation, clinical data, clinical evaluation and

1

This document is intended to provide an update on definitions and other terminology arising from regulatory

updates in different regions. It does not update methodology such that it reflects a (best practice) life cycle approach.

Page 4 of 8

October 10, 2019

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