【奥译言】IMDRF展开三项新的讨论

2018-07-30 13:37 阅读数：4727 标签：

2018年8月24日 Zachary Brennan

作为努力继续推动监管融合的一部分，国际医疗器械监管机构论坛（IMDRF）已经就标签、唯一器械标识（UDIs）和不良事件报告展开了三项新的讨论。

标签

这份31页的提议性文件由IMDRF良好监管审查实践小组于7月12日发布，旨在为医疗器械和IVDs提供统一的标签原则（内容和格式），并支持IMDRF的安全与性能基本原则。

该文件规定了通用标签原则，包括标签上的具体部分、使用说明和患者信息。该指南还介绍了作为医疗器械的软件的标签原则，以及仅供非专业人士使用的医疗器械和体外诊断产品（IVDs）的原则。

本次讨论将于2018年9月12日结束。

UDI

一份由UDI工作组于7月12日发布的60页的提议性指南文件为监管机构提供了一个框架以在协调的情况下发展其UDI系统。

该指南主要介绍了统一的UDI系统的基本要素、设计和操作这一系统的指导原则以及某个UDI的内容、结构和表示意义。

该指南还讨论了UDI在包装上的应用、UDI数据库以及确立建立和维护UDI系统的责任。

IMDRF写道：“只有当卫生保健相关人员在他们的系统中整合并从UDIs和相关唯一器械标识数据库（UDIDs）中获取数据时，才会实现UDI系统的益处和目的。”

工作组还发布了两份关于UDIs的附加信息文件。关于这份提议性指南文件的讨论将于2018年10月12日结束。

不良事件报告

由不良事件工作组准备的这份24页的讨论报告提供了一套统一的术语，用于报告与医疗器械，包括IVDs相关的不良事件。

“一套单一的、适当的不良事件术语和编码系统的广泛使用有望改善不良事件管理系统的信号监测，从而使行业和监管就够能够更快地做出反应”，IMDRF说到。

这次讨论将于2018年10月12日结束。

英语原文

IMDRF Opens Three New Consultations

Posted 24 July 2018 | By Zachary Brennan

As part of its continued push to foster global regulatory convergence, the International Medical Device Regulators Forum (IMDRF) has opened three new consultations on labeling, unique device identifiers (UDIs) and adverse event reporting.

Labeling

The 31-page proposed document, released 12 July by the IMDRF Good Regulatory Review Practices group, aims to provide globally harmonized labeling principles (content and format) for medical devices and IVDs and to support the IMDRF Essential Principles of Safety and Performance.

The document specifies the general labeling principles, including specific sections on the label, instructions for use and information intended for the patient. The guidance also features sections on labeling principles for software as a medical device and such principles for devices and in vitro diagnostics (IVDs) intended only for layperson use.

This consultation will close on 12 September 2018.

UDI

The 60-page proposed guidance, released by the UDI Working Group on 12 July, provides a framework for regulatory authorities that intend to develop their UDI systems in a globally harmonized approach.

The guidance features sections on the fundamental elements of a harmonized USI system, the guiding principles for designing and operating such a system, and the content, structure and representation of a UDI.

The guidance also discusses the application of a UDI to packaging, UDI databases and establishing responsibility for creating and maintaining a UDI system.

“The benefit and purpose of a UDI system will only be realized if healthcare stakeholders integrate and obtain value in their systems from UDIs and data in associated Unique Device Identification Databases (UDIDs),” IMDRF writes.

The working group also released two additional information documents on UDIs. The consultation on the proposed guidance will close on 12 October 2018.

Adverse Event Reporting

Prepared by the Adverse Event Working Group, this 24-page consultation features a harmonized terminology for reporting adverse events related to medical devices, including IVDs.

“Widespread use of a single, appropriate adverse event terminology and coding system is expected to improve signal detection by adverse event management systems enabling a faster response by both industry and regulatory authorities,” IMDRF said.

This consultation will close on 12 October 2018.

内容来自：Regulatory Affairs Professionals Society (RAPS)