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IMDRF/UDI WG/N7FINAL:2013 UDI Guidance Unique Device Identification (UDI) of Medical Devices - PDF (324kb)

赵静曼 6/25/2022 浏览 314 IMDRF/UDI WG/N7 世界范围

标准简介

UDI Guidance Unique Device Identification (UDI) of Medical Devices - PDF (324kb)[附网盘链接]是于9 December 2013发布的GHTF标准，适用于世界范围。

标准截图

UDI Guidance Unique Device Identification (UDI) of Medical Devices - PDF (324kb)[附网盘链接]
UDI Guidance Unique Device Identification (UDI) of Medical Devices - PDF (324kb)[附网盘链接](截图)

 

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标准部分原文

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1. Preamble

This document is inscribed in the framework of the International Medical Device Regulators

Forum (IMDRF). It replaces the "Guidance on a Unique Device Identification (UDI) System for

Medical Devices" adopted by the Global Harmonization Task Force (GHTF) on 16 September

2011.

The IMDRF Guidance on a "Unique Device Identification (UDI) System for Medical Devices"

clarifies and supplements the above mentioned GHTF Guidance by providing non-binding rules

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

IMDRF.

2. Introduction

This guidance provides a framework for those regulatory authorities that intend to develop their

UDI Systems that achieves a globally harmonized approach to the UDI. The framework can be

used at a local, national, or global level such that these systems are implemented without regional

or national differences. This guidance is intended to provide a high-level conceptual view of how

a global UDI System should work. It is recognized that further additional guidance may be needed

once these core concepts are accepted.

The fundamental concepts of a globally harmonized UDI System include:

a. the UDI and UDI Carrier are based on standards,

b. a UDI applied to a medical device anywhere in the world should be able to be used

globally and to meet the UDI requirements of its regulatory authority,

c. national or local identification numbers should NOT be a substitute for UDI,

d. regulatory authorities should not specify the procedure for modifying these UDI standards

e. the UDID core elements should not be modified,

f. the UDID should use the Health Level Seven International (HL7) Structured Product

Label (SPL) and web based interface for data submission,

g. every medical device needs to be identified by a UDI, unless it is exempted

The UDI System is intended to provide a single, globally harmonized system for positive

identification of medical devices. Healthcare professionals and patients will no longer have to

access multiple, inconsistent, and incomplete sources in an attempt to identify a medical device

and, its key attributes. The UDID is a designated source for additional information. It is critical to

note that the benefits of UDI can only accrue if all stakeholders, from the manufacturer to

healthcare providers and patients, use UDI throughout their workflow systems. Therefore, it is

imperative that all stakeholders be educated about the development and use of a UDI System.

9 December 2013 Page 3 of 19

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