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IMDRF/Registry WG/N46 FINAL:2018 Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making - PDF (479kb)

赵静曼 6/28/2022 浏览 275 IMDRF/Registry WG/N46 世界范围

标准简介

Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making - PDF (479kb)[附网盘链接]是Patient Registries Working Group发布的GHTF标准，适用于世界范围。

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Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making - PDF (479kb)[附网盘链接]
Tools for Assessing the Usability of Registries in Support of Regulatory Decision-Making - PDF (479kb)[附网盘链接](截图)

 

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标准部分原文

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1.0 Introduction

Registries (including registry consortia and strategically coordinated registry networks -CRNs) are

critical data infrastructure for capturing outcomes associated with medical device use, and as such

continue to demonstrate an impact on the quality of clinical

care worldwide. In 2014 the International Medical

Device Regulators Forum (IMDRF) identified a

significant gap in optimal use of registries for regulatory

decision making. This led to the creation of IMDRF

Registry Working Group that produced two documents to

guide alignment and use of registries generated data with

regulatory decision making needs; (1) Principles of

International System of Registries Linked to Other Data

Sources and Tools, (2) Methodological Principles in the

Use of International Medical Device Registry Data.

In the first document on Principles of International System of

Registries Linked to Other Data Sources and Tools, the

registry system was defined and eight registry qualifiers

were identified to enhance its impact and sustainability

(Figure 1). The Second document provides guidance on

Methodological principles in the clinical evaluation of

performance/effectiveness and safety across the device

lifecycle using international Coordinated Registry Networks (iCRNs) as well as in signal detection

Figure 1. IMDRF Context: Relationship

via iCRNs.

Between the Registry Documents

2.0 Scope

The purpose of this document is to provide guidance to regulators of medical devices, registry

organizations and other interested parties on the use of registry-generated data in support of

regulatory decisions. Such decisions include (a) initial device approval (when applicable), (b)

expanded/broadened indications, (c) post-market studies, (d) post-market surveillance, (e)

development of objective performance criteria (OPCs)/performance goals (PGs) and (f) device

tracking; and (g) field safety correction actions.

This document identifies key processes and features to be considered in assessing the usability of

registry data for regulatory purposes, encompassing both (a) data produced by registries and (b)

data produced by registry linkability to other sources (including other registries) to enrich the

evidence available for regulatory decision-making. These assessment elements are intended to

apply to both (a) purpose-built medical device registries (including those sponsored by

manufacturers) and (b) other types of patient registries (e.g. quality registries), such as those that

assemble data on surgical procedures that have a potential to generate data about medical devices.

The authors of this document recognize that data produced by a registry may be suitable for making

one type of regulatory decision but not others. Individual country regulators are expected to both (a)

assess independently the suitability of registry-generated data for regulatory purposes and (b)

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