NOTEÂ 1Â Â Â Â Â Â Â 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.
NOTEÂ 2Â Â Â Â Â Â Â 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.
Status : PublishedPublication date : 2021-04
Edition : 1Number of pages : 72
Technical Committee:Quality management and corresponding general aspects for medical devices
Buy this standard
|PDF + ePub|