New Symbol for Medical Device Labels: Greater Clarity and Safety in Communication

Labeling of medical devices is a critical step to ensure safety, regulatory compliance, and effective communication among manufacturers, healthcare professionals, authorities, and users. One of the most important elements of this labeling is the use of standardized symbols, which convey essential information clearly, universally, and without language barriers.

Addendum to ISO 15223-1: New Symbol for Authorized Representative (European Representative)

The ISO 15223-1 standard, which defines the symbols to be used on labels, packaging, and instructions for use of medical devices, was updated in May 2025 with the publication of the 1st Addendum. This addendum introduces an important change to the symbol referring to the Authorized Representative (the manufacturer’s European Representative).

Previously, the symbol consisted of the letters "EC REP", where "EC" stood for the European Community. However, according to ISO 3166-1, the code "EC" officially corresponds to the Republic of Ecuador, which led to ambiguity and potential misinterpretations.

New Symbol Aligned with ISO 3166-1

To resolve this duplication of meanings, the new symbol retains the original format but replaces the letters "EC" with the country or region code where the Authorized Representative is based (XX), as established by ISO 3166-1. For example, for representatives in the European Union, the new symbol will consist of the letters "EU REP".

Advantages of the New Symbol

• Greater clarity and accuracy in identifying the Authorized Representative

• Elimination of linguistic and geographical ambiguities

• Compliance with internationally recognized standards

• Easier enforcement by regulatory authorities

The adoption of this updated symbol improves transparency in the relationships between manufacturers, users, and regulatory authorities, and enhances trust in the labeling of medical devices.

Manufacturers: Adopt the New Symbol!

If you are a Cinterqual client, this is the symbol that must appear on the labeling of your medical devices. Proper and consistent implementation of this change is essential to ensure uniform and safe interpretation by all parties involved.

Need Support?

If you need guidance with the documentation and labeling of medical devices, contact our team.Cinterqual is here to help you keep your products compliant with applicable legislation and aligned with the latest international standards.

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