ISO 20417
ISO 20417 provides general requirements for information supplied by medical device manufacturers, from device identification and labels to packaging and instructions for use.
What is ISO 20417?
ISO 20417:2026 provides general requirements for information supplied by a medical device or accessory manufacturer. Its scope includes identification, labels, packaging information, markings, and accompanying information such as instructions for use and technical descriptions.
The standard creates a common baseline that product-specific or group standards can build on. More specific standards can impose additional requirements or take precedence for a particular device type.
What changed in ISO 20417:2026?
The 2026 edition is the second edition and replaces the withdrawn ISO 20417:2021. ISO identifies changes including updated normative references, removal of several former informative annexes, and introduction of the concept of an “applicable policy.”
Manufacturers that previously claimed conformity to the 2021 edition should assess the revised requirements, update their standards register, and document the effect on labels, accompanying information, specifications, and verification records.
What types of information does ISO 20417 address?
The standard addresses common information elements and how they are used across device labels, packaging, markings, instructions for use, and other accompanying materials. Examples include device and manufacturer identification, dates, catalogue or model identifiers, production control identifiers, sterile status, and information necessary for safe and effective use.
It defines what information is expected at a general level but does not prescribe a single delivery medium for every item.
How is ISO 20417 different from ISO 15223-1?
ISO 20417 covers the wider manufacturer-supplied information framework. ISO 15223-1 specifies graphical symbols that may be used to express some of that information. A complete labeling assessment should consider both standards as well as UDI, product-specific standards, risk controls, and local law.
Does compliance create one label that works worldwide?
No. Authorities can impose different identification, language, marking, and documentation requirements. Manufacturers must map the standard to each target jurisdiction.
Pure Global maintains market-specific guidance for requirements such as Malaysia MDA labeling, Thailand medical device labeling, and Vietnam labeling. A global label strategy should preserve a controlled core while documenting each market’s required variants.
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