Framework
ISOISO 20417:2021
ISO 20417:2021 specifies the requirements for information supplied by the manufacturer with a medical device, including the information on the label, in the instructions for use, and in technical descriptions. It provides a comprehensive framework for determining what information must be communicated and how it should be presented to ensure safe and effective use of the device.
Overview
Background
Published by the International Organization for Standardization (ISO), this standard consolidates and harmonizes the requirements for medical device information. It was developed to provide a single reference for labeling and information requirements, replacing fragmented requirements across multiple standards and supporting consistency with the EU MDR/IVDR labeling requirements.
Applicability
This standard applies to manufacturers of medical devices, including in vitro diagnostic devices, who need to provide information with their products. It covers all forms of information supplied by the manufacturer, including labels, instructions for use, technical descriptions, and promotional materials. It is relevant to all markets and is particularly referenced in the context of EU MDR and IVDR compliance.