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IMDRF/Standards WG/N51 FINAL:2018 Optimizing Standards for Regulatory Use - PDF (769kb)

赵静曼 5/30/2022 浏览 178 IMDRF/Standards WG/N51 世界

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Optimizing Standards for Regulatory Use - PDF (769kb)[附网盘链接]是IMDRF Standards Working Group发布的GHTF标准，适用于世界。

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Optimizing Standards for Regulatory Use - PDF (769kb)[附网盘链接]
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____________________________IMDRF Standards WG/N51 FINAL: 2018______________________________

Preface

The document herein was produced by the International Medical Device Regulators Forum

(IMDRF), a voluntary group of medical device regulators from around the world. The document

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 International Medical Device Regulators Forum.

1.0 Introduction

1.1 Background

Standards play a significant role in the design, production, post-production and regulation of

medical devices throughout their lifecycle. Important tools for conformity assessment, standards

facilitate and support innovation and help ensure that devices are safe and perform as intended.

Standards offer a means to streamline and harmonize regulatory processes around the world,

especially as medical devices grow in complexity and international markets expand. Standards

can be particularly valuable as they ‘… generally reflect the best experience of industry,

researchers, consumers and regulators worldwide, and cover common needs in a variety of

1

countries….’

As standards have grown in prominence in recent decades, evidence of their utility compels

industry, Standards Developing Organizations (SDOs), Regulatory Authorities (RAs), academia,

clinicians, public health experts and patients to dedicate resources to the development and

promulgation of standards. However, standards are frequently written in ways that diminish their

utility in regulatory processes. For example, some standards do not sufficiently contemplate

conformity assessment testing needs. Other standards are too flexible or unclear in expectations,

or do not meet a specific need, either for the market or regulators. These and other challenges

highlight the importance of considering how medical devices are regulated when building a

standard, so that a firm’s declaration of conformity with it will augment reviewers’ confidence

and streamline the approval process. See Appendix A for more information.

In preparing this guidance, IMDRF learned that while all its member regions use standards for

regulatory purposes, they differ in how they apply and/or recognize them. In addition, IMDRF’s

research found that RAs’ active participation in the standards development processes of two

international SDOs, the International Organization for Standardization (ISO), the International

Electrotechnical Commission (IEC) as well as their corresponding national/mirror committees is

uneven, and resource constraints, particularly time and people, hinder a robust and effective RA

representation.

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http://www.iec.ch/about/activities/standards.htm?ref=home, accessed 18 June 2018

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5 November, 2018 Page 1 of 22

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