ISO 20417:2026
2026-03
ISO 20417:2026
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.
Benefits
- Supports consistent and reliable medical device identification and labelling practices
- Enhances patient safety by improving clarity of instructions and product information
- Facilitates regulatory compliance across different jurisdictions
- Improves traceability through standardized identification elements such as catalogue numbers or production identifiers
- Simplifies the development of product-specific standards by providing common information requirements
FAQ
No. It defines what information needs to be supplied, but not the specific means or format used to provide that information.
It is primarily intended for medical device manufacturers and organizations involved in device design, production, labelling, regulatory compliance and quality management.
By ensuring that essential device information is clearly defined and communicated, the standard complements risk management approaches such as those described in ISO 14971, helping reduce misuse and improve safe operation.
General information
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Status: PublishedPublication date: 2026-03Stage: International Standard published [60.60]
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Edition: 2Number of pages: 51
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Technical Committee :ISO/TC 210ICS :11.040.01
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Life cycle
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Previously
WithdrawnISO 20417:2021
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Now
