IMDRF RPS WG/N45FINAL:2017 Data Exchange Guidelines - Common Data Elements for Medical Device Identification - PDF (1084kb)

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Data Exchange Guidelines - Common Data Elements for Medical Device Identification - PDF (1084kb)[附网盘链接]是于16 March 2017发布的GHTF标准，适用于全球范围。

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1 Introduction

The International Medical Device Regulators Forum (IMDRF) was conceived in February 2011

as a forum to discuss future directions in medical device regulatory convergence. It is a voluntary

group of medical device regulators from around the world who have come together to build on

the strong foundational work of the Global Harmonization Task Force (GHTF). The Forum will

accelerate international medical device regulatory harmonization and convergence.

Regulators require submission of device identification information at different points in the

regulatory life cycle of a medical device. Structured device identification information in standard

electronic format is expected (now or in the future) to be included as part of pre-market

submission, post-marketing distribution and use (disposal and discard), adverse event/vigilance

reporting, and corrective field actions (e.g., recall, advisory notices).

Once the medical device is commercially available, a Unique Device Identification (UDI) system

is expected to capture the device identification data elements at the level of a particular medical

device. However, at the point of initial regulatory submission, specific medical device

identification data elements are not always assigned. Therefore it would be useful to establish

common data elements which can be defined throughout the life cycle. These data elements are

not currently identified resulting in the lack of a consistent nomenclature, definitions and

structure for submission of this identifying information. Each type of submission may reference

the product differently. For example, a regulatory submission may refer to the medical device’s

trade name, the data attributes associated with UDI may contain brand name and a recall may

refer to proprietary name – all referring to the same medical device. The identification

information is also often submitted in an unstructured way; through regulatory submission forms

and other unstructured documents. The combination of different ways to identify a medical

device and the unstructured way medical device information is submitted make it difficult over

time to reconcile references to the same medical device.

Work was completed to define the common data elements to address the inconsistencies and lack

of harmonized definitions used for the submission of medical device information to regulatory

authorities (see IMDRF/RPS WG/N19 FINAL:2016, Common Data Element for Medical Device

Identification). With the harmonization of terms and their definitions, there is a future possibility

of electronic regulatory submission of device identification information and potential for reuse of

the common data elements for use in postmarket initiatives such as capture of device

identification information in adverse events, recalls and as part of patient registry design. This

document will provide data exchange guidelines to be used when other IMDRF working groups

are assigned to develop technical implementation guides for specific uses (e.g., premarket

regulatory submissions or reporting of device identification information in postmarket). These

guidelines provide a common framework that will allow effective, technically consistent

exchange of medical device identification information across the device lifecycle.

2 Scope

This document outlines the data exchange guidelines for the common data elements identified in

the Common data elements for medical device identification (IMDRF/RPS WG/N19) document.

The guidelines in this document may be used through regulatory activities or processes,

16 March 2017 Page 11 of 122

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