ISO FDIS 20417
Medical devices — Information to be supplied by the manufacturer
|Publication Date:||3 April 2020|
|ICS Code (Medical equipment in general):||11.040.01|
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, their 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 Some authorities with 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.
An asterisk (*) as the first character of a title or at the beginning of a paragraph or table title indicates that there is guidance or rationale related to that item in Annex A.