ISO 15223-1-2021 amd1-2025 PDF

Full title and description

ISO 15223-1:2021/Amd 1:2025 — 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 modification of the EC REP symbol so it is not specific to a single country or region.

Abstract

This amendment to ISO 15223-1:2021 updates the Part 1 general requirements by adding a defined term for "authorized representative" (mandataire) and by revising the graphical EC REP (authorized representative) symbol to remove country/region‑specific elements. The change is a narrow, editorial and graphical amendment intended to align symbol use with regulatory and international market needs.

General information

• Status: Published.
• Publication date: 3 March 2025 (Edition: 2025/Amd 1).
• Publisher: International Organization for Standardization (ISO), prepared by ISO/TC 210.
• ICS / categories: 01.080.20; 11.040.01 (graphical symbols / medical equipment in general).
• Edition / version: Applies to ISO 15223-1:2021 (4th edition) with Amendment 1 (2025).
• Number of pages: 3 (amendment document).

Scope

This amendment applies to Part 1 of ISO 15223 (general requirements for symbols to be used with information supplied by manufacturers) and is limited to the addition of a defined term for "authorized representative" and the modification of the EC REP symbol so it is neutral with respect to country or region. It does not introduce new symbol families beyond updating the definition and the specific EC REP graphic.

Key topics and requirements

• Addition of a defined term for "authorized representative" (mandataire) to the terms and definitions.
• Modification of the EC REP (authorized representative) graphical symbol so it is not specific to any single country or region.
• Clarification of the use and presentation of symbols in manufacturer information consistent with ISO 15223-1 general requirements.
• Editorial / graphical amendment (short, focused change — small document intended to be applied alongside ISO 15223-1:2021).

Typical use and users

Primary users are medical device manufacturers, regulatory affairs professionals, labeling and artwork designers, notified bodies and conformity assessment organizations, test houses, and national standards bodies. The amendment is used when implementing or updating device labeling and information to ensure the EC REP symbol and related terminology meet the revised international requirement.

Related standards

Related documents and standards include the base standard ISO 15223-1:2021 (Part 1 general requirements), ISO 15223-2:2010 (symbol development, selection and validation), and national/adopted versions such as BS EN ISO 15223-1:2021+A1:2025 where applicable. Other relevant standards for labeling and usability include ISO 13485 and ISO 20417 (information to be supplied by the manufacturer), as referenced in regulatory and standards guidance.

Keywords

medical devices, symbols, labeling, EC REP, authorized representative, ISO 15223-1, amendment 2025, graphical symbols, ISO/TC 210.

FAQ

Q: What is this standard?

A: It is Amendment 1 (2025) to ISO 15223-1:2021, the international standard that defines symbols to be used with information supplied by medical device manufacturers (Part 1: General requirements).

Q: What does it cover?

A: The amendment adds a formal definition for "authorized representative" and revises the EC REP (authorized representative) symbol to be region-neutral. It is a focused editorial/graphical change applied to ISO 15223-1:2021.

Q: Who typically uses it?

A: Medical device manufacturers, regulatory and labeling teams, conformity assessment bodies, and standards/technical committees involved in device marking and information.

Q: Is it current or superseded?

A: The amendment is published and current as of 3 March 2025; it does not supersede ISO 15223-1:2021 but amends it (i.e., the base 2021 standard remains in force with this amendment applied). Check national adoptions for local publication/endorsement dates.

Q: Is it part of a series?

A: Yes — ISO 15223 is a multipart series. Part 1 defines general requirements and symbols; Part 2 (ISO 15223-2:2010) describes symbol development, selection and validation. This amendment applies only to Part 1.

Q: What are the key keywords?

A: EC REP, authorized representative, symbols, labelling, medical devices, ISO 15223-1, amendment 2025.