International
Standard
ISO 15223-1
Medical devices — Symbols to Fourth edition
be used with information to be 2021-07
supplied by the manufacturer — AMENDMENT 1
Part 1: 2025-03
General requirements
AMENDMENT 1: Addition of defined
term for authorized representative
and modified EC REP symbol to not be
country or region specific
Dispositifs médicaux — Symboles à utiliser avec les informations
à fournir par le fabricant —
Partie 1: Exigences générales
AMENDEMENT 1: Ajout du terme défini représentant autorisé
(mandataire) et modification du symbole EC REP pour ne pas
être spécifique d’un pays ou d’une région
Reference number
ISO 15223-1:2021/Amd.1:2025(en) © ISO 2025
ISO 15223-1:2021/Amd.1:2025(en)
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© ISO 2025 – All rights reserved
ii
ISO 15223-1:2021/Amd.1:2025(en)
Foreword
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This document was prepared by Technical Committee ISO/TC 210, Quality management and corresponding
general aspects for products with a health purpose including medical devices, in collaboration with the
European Committee for Standardization (CEN) Technical Committee CEN/CLC/JTC 3, Quality management
and corresponding general aspects for medical devices, in accordance with the Agreement on technical
cooperation between ISO and CEN (Vienna Agreement).
A list of all parts in the ISO 15223 series can be found on the ISO website.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
© ISO 2025 – All rights reserved
iii
ISO 15223-1:2021/Amd.1:2025(en)
Medical devices — Symbols to be used with information to be
supplied by the manufacturer —
Part 1:
General requirements
AMENDMENT 1: Addition of defined term for authorized
representative and modified EC REP symbol to not be country or
region specific
Clause 3
Add the following term after 3.19:
3.20
authorized representative
natural or legal person established within a country or jurisdiction who has received a written mandate
from the manufacturer to act on his behalf for specified tasks with regard to the latter’s obligations under
that country or jurisdiction’s legislation
[SOURCE: ISO 13485:2016, 3.2]
Clause 5, Table 1
Replace item 5.1.2 with the following:
© ISO 2025 – All rights reserved
1
ISO 15223-1:2021/Amd.1:2025(en)
5.1.2 Authorized Indicates the The [XX] text of NOTE 1 Additional — N/A
representative authorized the symbol shall guidance can be found
representative be replaced in ISO 20417[15],
in the identi- by either the ISO 18113-1[10],
fied country or two-letter ISO 18113-2[11],
jurisdiction country code or ISO 18113-3[12],
the three-let- ISO 18113-4[13] and
ter country ISO 18113-5[14].
code defined NOTE 2 If multiple
in ISO 3166-1 symbols (i.e. Author-
or other text ized representative,
required by the Importer, Distributor,
authority Translation, or Repack-
having aging) identify the same
jurisdiction. responsible entity, the
This name and address need
symbol shall be not be duplicated, and all
accompanied applicable symbols can be
by the name grouped together next to
and address of the single address.
the authorized NOTE 3 Not all
representative authorities having
adjacent to the jurisdiction recognize the
symbol. two-letter or three-letter
country codes found in
ISO 3166-1.
Annex A
Change the title of Clause A.4 to:
Example of use of symbol 5.1.2 “Authorized representative”
Change the content of Clause A.4 to:
© ISO 2025 – All rights reserved
2
ISO 15223-1:2021/Amd.1:2025(en)
Examples of use for
an authorized
representative in
different countries
or jurisdictions
© ISO 2025 – All rights reserved
3
ICS 01.080.20; 11.040.01
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