ISO 20417:2026

Medical devices — Information to be supplied by the manufacturer (Edition 2, 2026)

What is ISO 20417?
ISO 20417 specifies the general requirements for information supplied by the manufacturer for medical devices and accessories, including identification, labelling, packaging information, marking and accompanying documentation such as instructions for use.

The standard provides a central framework of common requirements that can be used by specific product or group standards for medical devices. This allows those standards to focus on device-specific needs while ensuring consistent baseline expectations for information and labelling.

This second edition replaces ISO 20417:2021 and has been technically revised. Updates include revised normative references, removal of several informative annexes and the introduction of the concept of an “applicable policy”.

Why is ISO 20417 important?
Clear, accurate and consistent information is essential for the safe and effective use of medical devices. Labelling, packaging details and accompanying documentation help users understand device characteristics, usage conditions, risks and handling requirements.

ISO 20417 helps manufacturers structure this information in a consistent and internationally recognized way. It supports regulatory compliance, facilitates risk management and improves communication across supply chains and healthcare environments.

By establishing common identification and labelling requirements, the standard also promotes traceability and transparency throughout the lifecycle of medical devices.
General information
Status : Published
Publication date : 2026-03
Stage : International Standard published
Edition : 2
Number of pages : 51