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BSI BS EN ISO 20417:2021

Medical devices. Information to be supplied by the manufacturer
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BSI BS EN ISO 20417:2021

Medical devices. Information to be supplied by the manufacturer

PUBLISH DATE 2021
PAGES 84
BSI BS EN ISO 20417:2021
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.

SDO BSI: British Standards Institution
Document Number ISO 20417
Publication Date May 10, 2021
Language en - English
Page Count 84
Revision Level
Supercedes
Committee CH/210
Publish Date Document Id Type View
April 8, 2026 BS EN ISO 20417:2026 Revision
May 27, 2022 BS EN ISO 20417:2021 Revision
April 13, 2021 BS ENISO 20417:2021 Revision
May 27, 2022 BS EN ISO 20417:2021 Consolidated
May 10, 2021 BS EN ISO 20417:2021 Consolidated