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ISO/DIS 20417

Medical devices — Information to be supplied by the manufacturer

General information

40.99     3 qer 2025

ISO

ISO/TC 210

International Standard

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.

Life cycle

PREVIOUSLY

PUBLISHED
ISO 20417:2021

NOW

IN_DEVELOPMENT
ISO/DIS 20417
40.99 Full report circulated: DIS approved for registration as FDIS
3 qer 2025