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IMDRF/Registry WG/N42FINAL:2017 Methodological Principles in the Use of International Medical Device Registry Data - PDF (660kb)

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标准简介

Methodological Principles in the Use of International Medical Device Registry Data - PDF (660kb)[附网盘链接]是IMDRF Patient Registries Working Group于16 March 2017发布的GHTF标准，适用于全球。

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Methodological Principles in the Use of International Medical Device Registry Data - PDF (660kb)[附网盘链接]
Methodological Principles in the Use of International Medical Device Registry Data - PDF (660kb)[附网盘链接](截图)

 

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标准部分原文

1.0 Introduction

The International Medical Device Regulators Forum (IMDRF) Registry Working Group

was created with the purpose of developing:

(1) Essential principles for linking electronic patient, device and outcome registries

and/or related data repositories or identifiers such as Unique Device Identifiers

(UDIs), including the principles behind data access, security, informatics formats,

governance and other key areas related to global regulatory applications for

medical device evaluation; and

(2) Essential principles related to optimal methodologies for analysis of

heterogeneous data sources applied to medical device safety signal detection,

performance and reliability.

This document focuses on the task described in (2). In doing so, the document leverages the

essential principles behind data access, security, informatics formats and other key areas

related to global applications for medical device information described in (1). It applies the

medical device registry definition from (1) and introduces the methodological concept of

international Coordinated Registry Networks (iCRNs) to maximize the potential of data

captured in the international registries.

This methodological document also builds on the IMDRF Common Data Elements (CDE)

for Medical Device Identification document. The CDE effort outlines the common data

elements for medical device identification that may be used through regulatory activities or

process (pre-market, and post-market), including the future possibility of electronic

regulatory submission of device identification information and covers the harmonization of

terms and their definitions (IMDRF CDE).

Much of the material presented and developed here was preceded by multi-stakeholder

work advanced by the U.S. National Medical Device Registry Task Force. In particular, the

methods discussed there should apply reasonably directly to the international setting. This

document highlights aspect of those considerations that differ in important ways from the

national setting (Medical Device Registry Task Force).

2.0 Scope

This document provides information and guidance on:

• International coordination in methodologies that would add value to multiple

international stakeholders including regulators;

• Methodological principles in the clinical evaluation of performance/effectiveness

and safety across the device lifecycle using international Coordinated Registry

Networks (iCRNs);

• Methodological principles in signal detection via iCRNs.

The focus will primarily be on implantable therapeutic devices, as this area represents

highest risk devices with most registry activities and opportunity to reach consensus.

16 March 2017 Page 4 of 27

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