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IMDRF/PMD WG/N49 FINAL:2018 Definitions for Personalized Medical Devices - PDF (165kb)

赵静曼 5/7/2022 浏览 300 IMDRF/PMD WG/N49 世界

标准简介

Definitions for Personalized Medical Devices - PDF (165kb)[附网盘链接]是于18 October 2018发布的GHTF标准，适用于世界。

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Definitions for Personalized Medical Devices - PDF (165kb)[附网盘链接]
Definitions for Personalized Medical Devices - PDF (165kb)[附网盘链接](截图)

 

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标准部分原文

1.0 Introduction

The purpose of this IMDRF guidance is to establish harmonized definitions that are used to

describe medical devices that are intended for a particular individual. The adoption of consistent,

harmonized definitions for such medical devices could underpin a harmonized regulatory

approach for controls on these devices and offer significant benefits to the manufacturer, user,

patient, and to Regulatory Authorities. Eliminating differences between jurisdictions supports

global convergence and decreases the cost of gaining regulatory compliance and allows patients

earlier access to new technologies and treatments.

Technology has progressed from the time the original Global Harmonization Task Force (GHTF)

foundation documents were published. It is now possible to produce medical devices that are

individualized, for example, using additive manufacturing (3D printing) methods based on

patient CT scans, on a commercial rather than artisanal scale. The original GHTF documentation

does not adequately address devices of this nature.

Many jurisdictions already define the term custom-made device and have introduced exemption

provisions for regulating custom-made medical devices with the intention to cover special cases

where commercially available mass produced products are inadequate for the needs and

requirements of a particular patient. In some jurisdictions, the exemption provisions were based

on the premise that affected devices would largely comprise low risk products or limited use of

higher risk implantable devices. In other jurisdictions the exemption provisions were established

with the intention that numbers of custom-made devices would necessarily be small, due to the

requirement for them to be used only in special cases.

Now regulators are faced with a very different environment. Technology has made “custom-

made” devices, including implantable devices for particular patients, within reach on a much

greater scale. Consequently, some jurisdictions are noticing questionable use of custom-made

device exemptions; with growing numbers of patients receiving higher risk classification medical

devices to meet their particular needs, under these exemptions.

2.0 Scope

This document applies to all medical devices, and is intended to identify and describe different

categories of devices that are produced for the use of a particular individual, and also to define

some other terms that are relevant to defining these types of devices.

3.0 References

GHTF/SG1/N68:2012 Essential Principles of Safety and Performance of Medical Devices

GHTF/SG1/N78:2012 Principles of Conformity Assessment for Medical Devices.

GHTF/SG1/N70:2011 Label and Instructions for Use for Medical Devices.

GHTF/SG1/N071:2012 Definition of the Terms ‘Medical Device’ and ‘In Vitro Diagnostic

(IVD) Medical Device’

Page 2 of 8

18 October 2018

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