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ISO 20417:2026

Medical devices — Information to be supplied by the manufacturer

Mar 17, 2026

General information

60.60     Mar 17, 2026

ISO

ISO/TC 210

International Standard

11.040.01  

English   French  

Buying

Published

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Scope

NOTE 1        There is guidance or rationale for this Clause in A.2.1.
This document specifies the requirements for information supplied by the manufacturer for a medical device or 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

PREVIOUSLY

WITHDRAWN
ISO 20417:2021

NOW

PUBLISHED
ISO 20417:2026
60.60 Standard published
Mar 17, 2026

National adoptions

Medical devices - Information to be supplied by the manufacturer (ISO/FDIS 20417:2025)

50.60   Close of voting. Proof returned by secretariat

Z076 more

Medical devices - Information to be supplied by the manufacturer (ISO/FDIS 20417:2025)

50.60   Close of voting. Proof returned by secretariat

Z076 more