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.

Begin

2024-01-15

WI

JT003074

Planned document number

DIN EN ISO 20417

Project number

17600072

Responsible national committee

NA 176-01-02 AA - Quality management and corresponding general aspects for medical devices  

Responsible european committee

CEN/CLC/JTC 3 - Quality management and corresponding general aspects for medical devices  

Responsible international committee

ISO/TC 210/WG 2 - General aspects stemming from the application of quality principles to medical devices  

draft standard

Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024); German and English version prEN ISO 20417:2024
2024-12
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previous edition(s)

Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12); German version EN ISO 20417:2021
2022-03

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