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Standard

NEK EN ISO 20417:2021

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Services

Abstract

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 information

  • Standard from NEK
  • Published:
  • Edition: 2021-05
  • Version: 1
  • Document type: NAT
  • Pages
  • ICS 11.040.01
  • National Committee CEN/CLC/JTC 3

Legal references

EU law:
Law referenceRestrictions
2017/745
90/385/EEC
93/42/EEC

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