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Understanding the Latest Updates in ISO 15223:2025 for Medical Device Labelling

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Regulatory Specialist
Tue Apr 01 20254 min read

Understanding the Latest Updates in ISO 15223:2025 for Medical Device Labelling

To ensure safety and compliance, the medical device industry follows strict regulations. ISO 15223 standardizes labelling symbols to communicate important information clearly. The latest update, ISO 15223:2025, improves clarity, global compliance, and consistency in labelling.

The Importance of ISO 15223

Since medical devices are used globally, language differences can lead to misunderstandings of critical information. ISO 15223 establishes standardized symbols that effectively communicate essential details, such as manufacturer information, sterilization methods, expiration dates, and usage instructions. These symbols ensure healthcare professionals and patients can quickly interpret the necessary information without relying on translations.

What’s New in ISO 15223:2025?

The 2025 update to ISO 15223 introduces changes aimed at refining medical device labelling. The key revisions include:

1. Clearer Definition of "Authorized Representative"

The revised definition of the 'authorized representative' now aligns with international regulatory standards. To enhance regulatory transparency, ISO 15223:2025 includes a formal definition of an “authorized representative.” This update is particularly significant for manufacturers operating in regions where authorized representatives play a crucial role in medical device compliance and regulatory approval. The New definition of the “authorized representative” aligns with global regulatory expectations.

2. Updated EC REP Symbol for Universal Application

One of the major changes in this revision is the modification of the EC REP (European Authorized Representative) symbol. The updated version removes region-specific designations, making it more universally applicable. This change streamlines labelling requirements and reduces inconsistencies in global markets.

3. Change in EC REP Symbol Due to Ecuador’s Country Code

Traditionally, “EC REP” was used to indicate the European Authorized Representative. However, “EC” is also the ISO 3166-1 alpha-2 country code for Ecuador, leading to potential confusion in medical device labelling. To resolve this issue, ISO 15223-1:2021/Amd.1:2025 has officially changed the EC REP symbol to EU-REP to prevent misinterpretation. Additionally, the standard now requires the “[XX] REP” symbol to include a two-letter (e.g., DK) or three-letter country code as per ISO 3166 or any other text mandated by relevant authorities. The name and address of the authorized representative must also be placed adjacent to the symbol. These updates enhance clarity and consistency, ensuring that labelling symbols correctly convey their intended meaning without regional ambiguities.

Benefits of the ISO 15223:2025 Update

  • Improved Global Compliance: Aligns with international regulatory requirements, simplifying market entry for manufacturers.
  • Enhanced Clarity: Helps end-users and healthcare professionals understand essential information more easily.
  • Streamlined Labelling Processes: Reduces the need for region-specific variations, making compliance more straightforward.

How Manufacturers Can Prepare for ISO 15223:2025?

To ensure compliance with the latest standard, medical device manufacturers should take the following steps:

  • Review and Assess Changes: Identify how the new requirements impact current labelling strategies.
  • Update Labelling Systems: Implement necessary changes, including the revised EU-REP symbol and authorized representative details.
  • Train Internal Teams: Educate regulatory, design, and production teams about the updates to ensure smooth compliance.

Final Thoughts

ISO 15223:2025 brings significant advancements to medical device labelling, ensuring greater standardization and compliance in international markets. By adopting these updates, manufacturers can enhance safety, efficiency, and regulatory adherence. Are you a medical device manufacturer struggling to keep up with evolving labelling regulations and looking for expert guidance on ensuring compliance with ISO 15223:2025? At V-REG Solutions, we specialize in helping medical device manufacturers navigate complex regulatory changes with ease. We assist manufacturers in navigating complex regulatory landscapes, ensuring seamless compliance with ISO, MDR, and FDA requirements. At V-REG Solutions, we are committed to innovation, quality, and compliance, providing expert guidance to help you succeed in the global medical device industry.

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