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CEN - EN ISO 20417

Medical devices - Information to be supplied by the manufacturer

active, Most Current
Organization: CEN
Publication Date: 1 May 2021
Status: active
Page Count: 84
ICS Code (Medical equipment in general): 11.040.01
scope:

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.

 

 

 

Document History

EN ISO 20417
May 1, 2021
Medical devices - Information to be supplied by the manufacturer
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...

References

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