“Without translation, we would be living in provinces bordering on silence” ~ George Steiner

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Companies exporting their devices to international markets often underestimate the importance of translations. When it comes to the translation of your company’s medical device labels, your goal is to convey an important message to your end user and that is why excellence is the only option to have this crucial regulatory requirement fulfilled.

Translation errors could leave users unable to safely use your device, or in the worst case cause major patient harm or open your company to legal liability.

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‍Key points when Translating Medical Device Labeling

Needless to say, labels are not just something you can freely slap on the outside of the packaging. Medical device labeling includes everything from marketing materials to critical user instructions.

Here are a few key points to achieve high-quality translations:

→ Always rely on human translation with medical expertise: when it comes to healthcare documentation, medical device companies cannot afford mistakes. Effectiveness is most essential in translations, as a simple mistake can have major patient health or legal impact.

→ Translate concisely-steering clear of acronyms, which vary from language to language, and abbreviations, which also vary widely.

→ Avoid idioms and unnecessarily complicated terminology, as they often do not translate well across languages. When a simpler linguist choice that gets the point across is available, go with that.

→ Use accessible language, be sure to avoid jargon and keep instructions simple. Not only will this kind of language make it easier for everyone globally to understand, it will also make it easier to translate medical labels into the other languages required.

→ Use internationally recognized symbols and icons, whenever accepted. Many symbols and icons have become standardized and should be used wherever possible in medical device labeling to overcome language barriers.

It is important to stay up-to-date with medical device documentation translation requirements for the regions you are supplying.

Medical Device Regulation

Labeling is a key element of the Annex I General Safety and Performance Requirements all medical devices in the EU must fulfill to issue a Declaration of Conformity. This means that labeling must ensure all relevant elements are correctly translated to ensure the safe use and performance of the device intended purpose. To date, the Medical Device Regulation (MDR 2017/745) recognizes 24 official Union languages.

The IFU (Instructions for Use) shall have both general text and symbol definitions translated per Annex I, Section 23. IFUs constitute a majority of the necessary translations to Member State languages.

Labeling documents must be submitted for at least one of the Member State languages to be allowed on the market in the European Union (EU).

Countries that are not part of the EU are regulated separately. However, many companies think it may be profitable to add these languages to the labeling for the EU in order to take advantage of trade agreements.

In addition to being translated into the appropriate languages, the content for products intended for commercial use must be written so that it can be understood by a layperson. All patient information (especially instructions, safety warnings, precautions and contraindications) need be clear, unambiguous and straightforward to anyone.

Guidance Documents

As outlined by Mark Cusworth (VP Research & Development at PRISYMID) in his article “A Sticky Situation: Will your Labels Comply with EU MDR” (July 2018): “the definition of labeling has expanded to include items such as multi-language booklets and Instructions for Use [...]”.

And indeed, according to the MedTech Europe* guidance “Language implications of MDR for labelling of Medical Devices” (October 2020): “under MDR there is other documentation that will require translations into local languages, such as SSCP (Summary of Safety and Clinical Performance)”. The MDCG guidance on SSCP (MDCG 2019-9) states that the translations of SSCP are to be done in an analogous way with the IFU requirements in the given Member State. The SSCP part for patients must be always in the local language.

For the sake of patient safety, the ability to control these products’ labels at a global level is paramount. Labels must therefore be designed in a way that they are not only in the appropriate local languages, but also so that country-specific labeling requirements are met. They must ensure that nuances of country- specific designs and regulatory requirements are being understood sufficiently to communicate coherently with users. Any local language labeling errors can create the risk of brand damage; they can also lead to patient harm, legal liability, product misidentification, be deemed mislabeled and require field safety corrective actions such as recall, etc.

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Excellence as a Keyword

The precision of the information supplied with your medical device is essential to avoid costly mistakes and market entry delays; that will be key on the path to Excellence.

You may have a great product and a top distributor, but if your translations of device labels and IFU are poor, it may not only hurt sales and damage the reputation of your company but most importantly, and as outlined before, it can have an impact on patients’ health.

Complex and ever-changing international regulations are forcing manufacturers to incorporate language translation and localization (i.e. more comprehensive processes, addressing cultural & non-textual components plus linguistic issues when adapting for another country) into global development strategies.

Achieving harmonization will definitely be beneficial for medical device companies as well as patients because labeling process becomes simpler, avoid unnecessary duplication of efforts, save time and reduce costs.

This is beyond compliance: it is about patient’s well-being, trust and safety.

Always remember: poor translations pose a liability risk if a misunderstanding leads to misuse of your device by a patient or user - the more accurate the translation will be the safer (and happier) your end user will be! Be excellent!

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 * The European trade association for the medical technology industry.

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