Overview
EN ISO 15223-1:2021/A1:2025 is a CEN-adopted amendment to the international standard on medical device symbols used in manufacturer-supplied information. This Amendment 1 (ISO 15223-1:2021/Amd 1:2025) adds a defined term for authorized representative and updates the EC REP symbol so it is not specific to any single country or region. The document was approved by CEN and is intended to be implemented into national standards by May 2026.
Key topics and technical requirements
- Defined terms: introduction of a clear definition for authorized representative, improving consistency in labeling and regulatory references.
- EC REP symbol modification: revision of the traditional EC REP mark to a region-agnostic graphical symbol, enabling broader international use on labels and instructions for use.
- Graphical symbol principles: general requirements for symbols used on medical devices and packaging, including when symbols may replace text and how they relate to instructions for use.
- Labeling elements covered (as aligned in the standard and Annex ZA/ZB with EU requirements):
- Identification of manufacturer and authorized representative (address)
- Lot number / serial number replacement with symbols
- Date of manufacture and use/implant time limits (expiry)
- Indication of sterile state and sterilization method (symbol usage)
- Single-use designation and fragile/temperature/moisture handling symbols
- Symbols to draw attention to warnings, limitations and accompanying safety information
- Partial coverage of UDI carrier and other machine-readable requirements
- Relationship to EU regulation: informative annexes (ZA/ZB) map the standard’s clauses to General Safety and Performance Requirements of Regulation (EU) 2017/745 and 2017/746, clarifying areas of conformity and limitations.
Applications and who uses it
This amendment is essential for:
- Medical device manufacturers - to update labels, packaging and instructions for use with standardized symbols and to reflect the new EC REP symbol and defined authorized representative.
- Regulatory and quality teams - to demonstrate conformity with labeling-related General Safety and Performance Requirements and to prepare documentation for EU market placement.
- Designers and technical illustrators - for implementation of compliant graphical symbols on devices and packaging.
- Authorized representatives and notified bodies - for recognition of the new symbol and consistent interpretation across member states.
Using EN ISO 15223-1:2021/A1:2025 helps organizations harmonize medical device labeling, reduce language dependence, and align with EU regulatory expectations.
Related standards
- ISO 15223-1:2021 (base standard)
- Regulation (EU) 2017/745 (EU MDR) - informative Annex ZA/ZB links in the amendment explain coverage and limitations.
