Understanding EU medical device e-labeling requirements
Now that the European Union is moving toward e-labeling for medical devices, companies like yours are able to reduce the cost of delivering pertinent product and safety information. Digital delivery of label information ensures that product users always have up-to-date product information, which can even be delivered via video.
However, despite the ease in which e-labeling delivers information to the end user, many companies are still confused about translating for e-labels.
The Penalty of Not Translating Per Regulations
Many companies are so confused and stressed over meeting the complex EU regulations on medical device e-labeling that they sometimes forego it completely. Do this at your own risk. If you are caught being non-compliant with EU law, you will lose all the time and money you put into entering the new market, and of course, you won’t reap the benefits of selling your products in the giant marketplace that is the European Union.
Your products could be seized at the border, or you could be forced to recall your products. Your insurance company could even refuse to offer you liability insurance if you don’t properly translate your e-labels.
The purpose of requiring e-labels to be appropriately translated is to prevent injury or death. Naturally, you don’t want liability lawsuits, do you? If someone is injured due to not understanding how to properly use your device, you are at fault. Ignorance never stands up in court.
What Needs to be Translated
While certainly the electronic label for your medical device is required by law to be translated into local languages, it’s wise to go above and beyond and get everything related to your device translated, including:
- User Manuals
- Packaging
- Software
- Marketing Brochures
- Regulatory Filings
- Patents
- Patient Education Materials
You’ll never be penalized for translating more than required by law, and it can increase your appeal in a new marketplace if every piece of communication that relates to your product is available in the local language.
What You Need to Know About Translating e-Labels
Typically, having your device label translated into the five primary European languages (French, Spanish, German, Italian, Russian) will suffice, but make sure you’re not required to translate into less popular languages if you’re entering into smaller countries like Turkey or Greece.
Your translation should make it clear to a user how to use your device. To that end, use easy-to-understand language, and short and clear sentences. Avoid slang and colloquial phrases that may be misunderstood when translated.
Using universal medical device symbols can make it easy to communicate global concepts like “fragile” or “biological risks.”
Translating your medical device’s e-labels is key to your success in entering a new market in the European Union. Don’t let a lack of understanding about EU e-labeling requirements hurt you.
