Guidelines for translating the descriptions of ISO 15223 symbols used in medical devices

In this blog, we present an approach for translating the symbols found in medical device documentation, whether it be instructions for use, labelling, or packaging.

These symbols usually have accompanying descriptions, which must be translated when the devices are to be marketed in other countries.

What is the ISO 15223-1 standard?

The ISO 15223-1 standard, also known as 'Medical Devices. Symbols to be used with information to be supplied by the manufacturer', is an international standard published by the International Organization for Standardization (ISO). This standard provides a series of graphical symbols used for the labelling and packaging of medical devices.

The standard sets out requirements and guidelines for the use of these graphical symbols that provide information on the safe and effective use of medical devices.

The symbols defined in ISO 15223-1 are internationally recognised and their use facilitates effective communication and understanding of information related to medical devices, regardless of language or culture.

Is the use of ISO 15223-1 mandatory?

In the European Union, the answer is 'yes'. Manufacturers are required to comply with this standard to meet the regulation (MDR or IVDR).

In the MDR, Annex I, Chapter III, Article 23.1, h) states: 'Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols. Any symbol or identification colour used shall conform to the harmonised standards or CS.'

In the IVDR, Annex I, Chapter III, Article 20.1, h) states: 'Where appropriate, the information supplied by the manufacturer shall take the form of internationally recognised symbols, taking into account the intended users. Any symbol or identification colour used shall conform to the harmonised standards or CS.'

On the other hand, ISO 15223-1 is a harmonised standard, as established by the Commission Implementing Decision (EU) 2022/6 of 4 January 2022, for both medical devices and in vitro medical devices.

In the case of the FDA, ISO 15223-1 is officially recognised as a consensus standard for the use of symbols in the labelling of medical devices. 

According to the FDA regulation 21 CFR Part 801.15, the use of symbols without explanatory text is permitted, so long as they come from a recognised standard such as ISO 15223-1. In this sense, it is not mandatory to include a legend or glossary of symbols on the labelling, provided that these symbols are adequately explained in the product's instructions for use (IFU). This reduces the need for translation and simplifies how the information is presented.

Furthermore, in 2016, the FDA published a guide titled 'Use of Symbols in Labeling', which clarifies the conditions for the use of symbols without accompanying text in labelling. If non-standardised symbols or those not belonging to a recognised standard are used, then an explanatory glossary must be included on the labelling. Therefore, following ISO 15223-1 is not only accepted but recommended, provided that the presentation and clarity requirements established by the FDA are respected.

Use of official translations

Although there is no specific provision mandating the use of official translations, that is, translations of ISO 15223-1 carried out by the corresponding national standardisation body, it is strongly recommended, as this can prevent interpretations suggesting that it is a regulatory requirement.

In any case, with the use of official translations we can achieve the following:

Regulatory consistency

The versions translated by national bodies are harmonised with the original text approved by ISO. Using them ensures that the translated term maintains its technical and legal validity, especially if any notified body or health authority reviews the labelling or the IFU.

Recognition by competent authorities

In the context of Regulation (EU) 2017/745 (MDR), national market surveillance authorities (such as the AEMPS in Spain or the ANSM in France) expect to find the descriptions of symbols as they appear in the current harmonised standard in their official language. Changing or freely adapting these descriptions may be considered a non-compliance.

Avoiding misinterpretations

Unofficial translations or those made 'from scratch' can introduce ambiguities, non-technical terms, or misinterpretations. Using official translations reduces this risk, which is essential in a regulated sector focused on patient safety.

What to do when there is no official translation?

In the case of the European Union, one of the limitations of using official translations is that most national standardisation bodies do not have an official translation of ISO 15223-1. Only high-volume markets have an official translation. As a result, the standard is translated in Germany, Spain, France, Italy, and Portugal.

To achieve harmonisation of translations in other languages, we recommend using translations published by the trade association MedTech Europe. You can access this document here.

Using this MedTech Europe glossary is not recommended if there is already an official translation, as the translations published in other languages do not use those by national standardisation bodies.

Conclusion

We can conclude that using the translations published by national standardisation bodies is an approach that guarantees the quality of translations and their compliance with relevant legislation.

At AbroadLink, a translation company specialising in the translation of medical devices, we adopt and advocate this approach as the ideal way to offer accurate translations that ensure regulatory compliance and avoid delays due to possible misinterpretations by notified bodies or competent authorities.