ISO 15223-1 and the Authorized Representative Symbol

ISO 15223-1 is a crucial standard for medical device manufacturers, providing symbols to convey information about devices without relying on text. This minimizes translation needs, frees up label space, and meets various regulatory requirements. On March 5, 2025, ISO 15223-1:2021/Amd 1:2025 introduced a significant change to the Authorized Representative symbol, altering the [EC] part of the symbol to [XX]. This change allows the symbol to be used globally, not just within the European Union, by replacing [XX] with country codes or other recognized text.

The Concept of Authorized Representative

The use of Authorized Representative originated in the European regulatory framework, specifically within the EU Medical Device Directives (93/42/EEC) and the In Vitro Diagnostic Devices Directive (98/79/EC). These directives required a person or entity within the European Community to act on behalf of manufacturers outside of it, ensuring compliance with EU regulations. The symbol for the Authorized Representative was first introduced in EN 980:2003 and later incorporated into ISO 15223-1:2012.

Why the Symbol Changed

The European Commission requested the change, pointing out that using EC to refer to the European Union was incorrect. The previous revisions did not fully address this concern, leading to the amendment. Although the change does not directly impact patient safety, it prevents potential complications such as the removal of EN ISO 15223-1 as a harmonized standard or the addition of explanatory text in device documentation.

International Harmonization

The decision to publish the amendment at the ISO level supports international harmonization, promoting best practices across different markets and reducing the need for separate standards. This approach aligns with the Vienna Agreement, ensuring ISO standards are adopted as European Standards and avoiding duplication of efforts.

Approval Process

Drafting and publication of the amendment followed the ISO process, with consensual agreement from all member bodies. After discussions with the European Commission and feedback from WG3 members, the amendment received 100% approval in the DIS ballot, allowing it to proceed directly to publication.

Usage and Transition Period

The amended symbol can now be used globally, with specific requirements for replacing the [XX] text. The transition period for changing from EC REP to EU REP in the European Union depends on the EU's harmonization process and publication of an Implementing Decision in the OJEU. This process can be lengthy, and a 3-year transition period will be recommended to the Commission.

Conclusion

The amendment to the Authorized Representative symbol in ISO 15223-1 is a significant change with broad implications. While it addresses concerns raised by stakeholders, it also highlights the importance of international harmonization and regulatory coherence. Manufacturers and stakeholders should direct their concerns to the EU Commission or organizations like MedTech Europe.