ISO 20417:2026 has been published, setting out updated general requirements for the information to be supplied by manufacturers of medical devices and their accessories. The standard covers key elements such as device identification, labelling, packaging information, marking, and accompanying documentation, including instructions for use.
ISO 20417 continues to serve as a foundational framework, establishing common requirements that can be referenced by product- or device-specific standards. This approach enables those standards to address particular device characteristics while maintaining consistent baseline expectations for information and labelling across the sector.
This second edition replaces ISO 20417:2021 and introduces a number of technical revisions. Notably, it includes updated normative references to align with current standards and regulatory developments, removes several informative annexes (Annexes D, F, G, and H), and introduces the concept of an “applicable policy” to further clarify compliance expectations.
Additional changes have been made to streamline the standard and improve clarity around manufacturer responsibilities, including the removal of item b) in Clause 4 and item d) 1) in Clause 6.1.2.
The updated standard can be accessed using the following link
