DNS/ISO 20417: 2021

MEDICAL DEVICES — INFORMATION TO BE SUPPLIED BY THE MANUFACTURER (ISO 20417: 2021, IDT)


Status: Public comments
Start date: 20240718
End date: 20240916

NOTE 1  There is guidance or rationale for this Clause contained in Clause A.2. 

This document specifies the requirements for information supplied by the manufacturer for a medical  device or by the manufacturer for 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. 


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