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ISO 20417:2021

Medical devices — Information to be supplied by the manufacturer

Apr 13, 2021
95.99   Withdrawal of Standard   Mar 17, 2026

General information

95.99     Mar 17, 2026

ISO

ISO/TC 210

International Standard

11.040.01  

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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.

Life cycle

NOW

WITHDRAWN
ISO 20417:2021
95.99 Withdrawal of Standard
Mar 17, 2026

REVISED BY

PUBLISHED
ISO 20417:2026

National adoptions

SRPS EN ISO 20417:2022  
ISS

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)

60.60   Standard published

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