IMDRF Consultation Feedback - GRRP WG - N52 - Principles of Labeling for Medical Devices (Edition 3)

Overview

The purpose of this IMDRF guidance is to provide globally harmonized labeling principles for medical devices, and support IMDRF/GRRP WG/N47 (Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices). Specifically, this document provides guidance on the content of the label, instructions for use (IFU), and information intended for the patient in order to support the safe and effective use of medical devices by their intended users. It also includes considerations related to the adoption and use of electronic labeling elements (also known as e-labeling).

This document has been developed to encourage and support global convergence of regulatory systems. It is intended for use by Regulatory Authorities (RAs), Conformity Assessment Bodies (CABs), industry, and others, and will provide benefits in establishing consistent labeling requirements in various jurisdictions. 

Comments should be limited to the use of electronic labeling elements, or to any of the other changes introduced in this version of N52.

IMDRF Affiliate Members and members of Regional Harmonization Initiatives are especially encouraged to comment on the Proposed Document contents.

Why your views matter

Labeling serves to identify a device and its manufacturer, and to communicate information on safety, use, and performance. In some jurisdictions, “labeling” is referred to as “information supplied by the manufacturer” and may be physical or electronic. Labeling includes the label, IFU and information related to the identification, technical description, intended purpose and proper use of the medical device, as applicable.  It is intended for users, both professional and lay persons, as appropriate, and for relevant third parties. 

The IMDRF Good Regulatory Review Practices (GRRP) Working Group appreciates your feedback which will be considered prior to finalization of the document for publication.