Exporting medical devices to EU?
Are you looking to export medical equipment to Europe? You might not be surprised to read that exporting medical equipment is a rather complex process. And believe it or not, the translation / localization piece is the least of your worries. Why, you ask? Because EPIC Translations fully understands the requirements for medical device translations.
If you’re looking to export to Europe, then consider the following:
- EU has 27 member countries. This list is likely to grow in the future.
- 500 million consumers speak 22 different languages
(Un)Fortunately, all EU countries have adopted the three EU Medical Directives:
- Active Implantable Medical Devices (AIMD);
- Medical Devices (MDD);
- In-Vitro Diagonistic Devices (IVD).
What does this mean for medical device manufacturers? Essentially that all labels and instructions must be localized to each country BEFORE the medical devices reach the end users in all EU countries. So, if you’re looking to increase your sales and export your medical devices to Belgium; then the labels and instructions for your medical devices MUST be localized to Dutch, French, & German. For Denmark, localization must be done in Danish. For Finland, localization must be done in Finnish AND Swedish. And so forth.
Here is a complete list of the EU countries, the languages, and what exactly has to be localized:
|Country||Language||What must be localized|
|Austria||German||AIMD, MD, IVD|
|Belgium||Dutch, French, & German||AIMD, MD, IVD|
|Cyprus||Greek||AIMD, MD, IVD|
|Czech Republic||Czech||AIMD, MD, IVD|
|Denmark||Danish||AIMD, MD, IVD|
|Estonia||Estonian||AIMD, MD, IVD|
|Finland||Finnish, Swedish||AIMD, MD, IVD|
|France||French||AIMD, MD, IVD|
|Germany||German||AIMD, MD, IVD|
|Greece||Greek||AIMD, MD, IVD|
|Hungary||Hungarian||AIMD, MD, IVD|
|Ireland||English||AIMD, MD, IVD|
|Italy||Italian||AIMD, MD, IVD|
|Latvia||Latvian||AIMD, MD, IVD|
|Lithuania||Lithuanian||AIMD, MD, IVD|
|Luxembourg||French, German, & Liezeburgish||AIMD, MD, IVD|
|Malta||Maltese or English||AIMD, MD, IVD|
|Netherlands||Dutch||AIMD, MD, IVD|
|Portugal||Portuguese||AIMD, MD, IVD|
|Slovenia||Slovenian||AIMD, MD, IVD|
|Spain||Spanish||AIMD, MD, IVD|
|Sweden||Swedish||AIMD, MD, IVD|
|United Kingdom||English||AIMD, MD, IVD|
Here is a map of the EU for your reference:
So as you can see, exporting your medical devices to the EU is a little bit more challenging than exporting textiles or financial services. However, partnering with a Language Services Partner (LSP) that understands the rules and regulations for the medical device industry will make things much easier for you. EPIC Translations has linguists in every single country in the EU that specialize in medical devices. Thus, we can provide you with not just accurate translations, but also create a terminology database for you that will help you in your future endeavors.