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ISO 20417:2026

Medical devices - Information to be supplied by the manufacturer
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NOTE 1        There is guidance or rationale for this Clause in A.2.1.

This document specifies the requirements for information supplied by the manufacturer for a medical device or an accessory, as defined in 3.1. This document includes the generally applicable requirements for identification and labels on a medical device or accessory, the packaging, marking of a medical device or accessory, and accompanying information. This document does not specify the means by which the information is to be supplied.

NOTE 2        Some authorities having jurisdiction impose different requirements for the identification, marking and documentation of a medical device or accessory.

Specific requirements of medical device product standards or group standards take precedence over requirements of this document.

SDO ISO: International Organization for Standardization
Document Number ISO 20417
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 210
Publish Date Document Id Type View
Not Available ISO 20417:2026 Revision
April 1, 2021 ISO 20417:2021 Revision