prEN ISO 20417

Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024)

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.

Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen (ISO/DIS 20417:2024)

Dispositifs médicaux - Informations à fournir par le fabricant (ISO/DIS 20417:2024)

NOTE 1        Il y a des indications ou une justification pour cet Article figurant dans l'Article A.2.
Le présent document spécifie les exigences relatives aux informations fournies par le fabricant pour un dispositif médical ou un accessoire, tel que défini en 3.1. Le présent document contient les exigences génériques communes concernant l’identification et l’étiquetage d’un dispositif médical ou d’un accessoire, l'emballage, le marquage d’un dispositif médical ou d’un accessoire et les informations d’accompagnement. Le présent document ne spécifie pas le mode de transmission des informations.
NOTE 2        Certaines autorités compétentes imposent des exigences différentes concernant l’identification, le marquage et la documentation d’un dispositif médical ou d’un accessoire.
Les exigences spécifiques des normes de produit relatives à un dispositif médical ou des normes de groupe prévalent sur les exigences du présent document.

Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO/DIS 20417:2024)

General Information

• Status: Not Published
• Publication Date: 23-Jun-2026
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: CEN/CLC/TC 3 - Quality management and corresponding general aspects for medical devices
• Current Stage: 4020 - Submission to enquiry - Enquiry
• Start Date: 28-Nov-2024
• Completion Date: 28-Nov-2024
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Directive: 2017/746 - Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: oSIST prEN ISO 20417:2025 - Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024)

Relations

• Revises: EN ISO 20417:2021 - Medical devices - Information to be supplied by the manufacturer (ISO 20417:2021, Corrected version 2021-12)
• Effective Date: 10-Jan-2024

Standards Content (Sample)

SLOVENSKI STANDARD
01-januar-2025
Medicinski pripomočki - Informacije, ki jih zagotovi proizvajalec (ISO/DIS
20417:2024)
Medical devices - Information to be supplied by the manufacturer (ISO/DIS 20417:2024)
Medizinprodukte - Anforderungen an vom Hersteller bereitzustellende Informationen
(ISO/DIS 20417:2024)
Dispositifs médicaux - Informations à fournir par le fabricant (ISO/DIS 20417:2024)
Ta slovenski standard je istoveten z: prEN ISO 20417
ICS:
01.110 Tehnična dokumentacija za Technical product
izdelke documentation
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
International
Standard
ISO/DIS 20417
ISO/TC 210
Medical devices — Information to
Secretariat: ANSI
be supplied by the manufacturer
Voting begins on:
Dispositifs médicaux — Informations à fournir par le fabricant
2024-11-29
ICS: 11.040.01
Voting terminates on:
2025-02-21
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 20417:2024(en)
ISO/DIS 20417:2024(en)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
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Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO/DIS 20417:2024(en)
Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General considerations .12
5 Information elements to be established .13
5.1 Units of measurement . 13
5.2 Graphical information . 13
5.3 Language and country identifiers .14
5.3.1 Language identifiers .14
5.3.2 Country identifiers .14
5.4 Dates .14
5.5 Full address . 15
5.6 Commercial product name . 15
5.7 Model number . 15
5.8 Catalogue number . 15
5.9 Production controls . 15
5.10 Unique device identifier .16
5.11 Types of use/reuse .16
5.12 Sterile .16
6 Requirements for accompanying information .16
6.1 Requirements for information to be supplied on the label .16
6.1.1 Minimum requirements for the label .16
6.1.2 Identification of the manufacturer .17
6.1.3 Identification of the medical device or accessory .17
6.1.4 Other label requirements . 20
6.1.5 Consult instructions for use .21
6.1.6 Safety signs .21
6.2 Identification requirements for detachable components of a medical device or accessory . 22
6.3 Legibility of the label . 23
6.4 Durability of markings . 23
6.5 Information to be provided on the packaging . 23
6.5.1 General information . 23
6.5.2 Packaging for the lay user . 25
6.5.3 Special conditions indicated on the packaging . 25
6.6 Requirements for information in the instructions for use and technical description .27
6.6.1 General .27
6.6.2 Requirements for instructions for use . 28
6.6.3 Additional requirements for the instructions for use for a lay user .32
6.6.4 Requirements for technical description . 33
6.6.5 Requirements for e-documentation . 35
7 Other information that is required to be supplied with the medical device or accessory .36
7.1 Importer . 36
7.2 Distributor . 36
7.3 Repackaging . 36
7.4 Translation .37
7.5 Regulatory identification .37
Annex A (informative) Particular guidance and rationale .38
Annex B (informative) Example test method for assessing clearly legible requirements . 41
Annex C (informative) Example test method for assessing durability .42

iii
ISO/DIS 20417:2024(en)
Annex D (informative) Reference to the IMDRF essential principles and labelling guidances .43
Annex E (informative) Terminology — Alphabetized index of defined terms . 47
Annex ZA  Relationship between this European Standard and the General Safety and
Performance Requirements of Regulation (EU) 2017/745 aimed to be covered .49
Annex ZB (informative) Relationship between this European Standard and the General Safety
and Performance Requirements of Regulation (EU) 2017/746 aimed to be covered .58
Bibliography .65

iv
ISO/DIS 20417:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
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