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European Language Translation Requirements for Medical Device Labeling, IFUs and Software

Updated: Jul 5


Yes, it’s true. No, it’s not new. Yes, you need to take it more seriously than ever before. Here’s why. (Or skip the explanation and go directly to the language requirements list below.)

The Medical Devices Directive (MDD) always required manufacturers to confirm whether the translation of their labeling into the national language(s) of each European country where the device is sold was required. Yet, enforcement was not exactly robust. Manufacturers without a registered office in the EU have an EU Authorized Representative (EC REP) that is supposed to review labeling for compliance and that could include ensuring that the manufacturers’ they represent were aware of the national translation requirements. However, EC REPs did not always have clear insight into where products were being distributed in the EU after they reached a distributor. Adding to the confusion, many manufacturers of devices used by professionals mistakenly assume their labeling and Instructions for Use (IFU) can be in English only, regardless of the country where sold.

Now that the European Medical Device Regulation (2017/745) has taken effect, the requirements surrounding translation take on new importance to manufacturers. To be clear, the MDR doesn’t really impose any new language requirements (but read MDR Annex II(2) nonetheless) that weren't present in the MDD, but the compliance checks required from your Economic Operators (namely your distributor and importer) are much more robust now.


MedEnvoy can act as your independent importer in the EU, UK or Switzerland.

Your Distributor and Importer Will Be Watching Your Translations More Closely


Is your distributor in Athens going to comb through your Greek language IFU to ensure that everything has been translated correctly from English? Not likely. But they are surely going to make sure you have a Greek IFU in the first place because Article 14(2b) requires distributors to enforce Article 10(11) which reads:

“Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient.”

Article 16(3) also reinforces the need for distributors and importers to check for translations: “Distributors and importers shall ensure that they have in place a quality management system that includes procedures which ensure that the translation of information is accurate and up-to-date…

If your company exports to Europe, your importer is now a gatekeeper responsible for “placing” your products on the European market. Article 13 of the MDR spells out their responsibilities which include making sure you are in compliance with the labeling requirements outlined in the MDR. While Article 13 does not require your importer to check for translation, Article 16(3) makes it pretty clear that regulators expect the importer to check that language requirements have been met as part of their labeling review.

If you fail to meet translation requirements your importer could be held financially liable for your lack of compliance by a Competent Authority. Therefore, it is in their best interest to make sure that you meet all EU MDR language requirements which is, of course, why regulators added this “double check” to the MDR in the first place.

And just to make sure you take this seriously, they added one more clause:

Article 10(14) - Manufacturers shall, upon request by a competent authority, provide it with all the information and documentation necessary to demonstrate the conformity of the device, in an official Union language determined by the Member State concerned.

You Also Need to Add Information That Accompanies Your Device to Your Website


OK I think we've made the point that translations are important but there's one more requirement you should be aware of. Annex I, Section 23 of the EU MDR states: “Each device shall be accompanied by the information needed to identify the device and its manufacturer, and by any safety and performance information relevant to the user, or any other person, as appropriate. Such information may appear on the device itself, on the packaging or in the instructions for use, and shall, if the manufacturer has a website, be made available and kept up to date on the website…”

Notice the word “shall” in this passage which means it is not optional. Thus, make sure you are clearly posting your IFUs (all of them in all languages) on your website. Your distributor, importer, Notified Body or Competent Authorities (and even your competitors!) may check.


Don’t Forget to Translate Your Declaration of Conformity

Translations aren't limited to your product labeling and instructions for use. MDR Article 19(1) makes that clear: “The EU declaration of conformity shall state that the requirements specified in this Regulation have been fulfilled in relation to the device that is covered. The manufacturer shall continuously update the EU declaration of conformity. The EU declaration of conformity shall, as a minimum, contain the information set out in Annex IV and shall be translated into an official Union language or languages required by the Member State(s) in which the device is made available.”

Shown below are the medical device language requirements for devices sold in European countries. This includes all EU and EEA countries plus a few others. This information may not be fully complete and use this as a guide but in the case of professional use devices, always verify with a country’s Competent Authority before making decisions about labeling as there are many exceptions in specific situations. While it is convenient and less expensive to provide an IFU in English for a professional use device, consider the new risks doing so may present. If you are committed to selling in a market for the long term, it is highly recommended to provide your IFU and labeling in an official language of that country.


European Countries and Their Official Language(s)


Shown below are the medical device language requirements for devices sold in European countries. This includes all EU and EEA countries plus a few others. This information may not be fully complete and use this as a guide but in the case of professional use devices, always verify with a country’s Competent Authority before making decisions about labeling as there are many exceptions in specific situations. While it is convenient and less expensive to provide an IFU in English for a professional use device, consider the new risks doing so may present. If you are committed to selling in a market for the long term, it is highly recommended to provide your IFU and labeling in an official language of that country.


An * indicates that that English may be acceptable for devices used only by healthcare professionals. Even so it is always recommended to translate into an official language of that country.


AUSTRIA - German

BELGIUM - Dutch, French and German

BULGARIA - Bulgarian*

CROATIA - Croatian

CYPRUS - Greek* CZECH REPUBLIC - Czech

DENMARK - Danish

ESTONIA - Estonian*

FINLAND - Finnish and Swedish

FRANCE - French

GERMANY - German

GREECE - Greek

HUNGARY - Hungarian

ICELAND - Icelandic

IRELAND - English

ITALY - Italian

LATVIA - Latvian

LITHUANIA - Lithuanian

LICHTENSTEIN* - German

LUXEMBOURG - French or German*

MALTA - English or Maltese

NETHERLANDS - Dutch*

NORWAY - Norwegian

POLAND - Polish*

PORTUGAL - Portuguese

ROMANIA - Romanian*

SLOVAKIA - Slovakian

SLOVENIA - Slovenian*

SPAIN - Spanish

SWEDEN - Swedish*

SWITZERLAND - German, French and Italian

UKRAINE - Ukranian

UNITED KINGDOM - English


Don’t get careless with your translations. Mix up Slovenian and Slovakian and you’ll surely hear about it. And whatever you do, don't cut corners and use your Brazilian Portuguese IFU translation for devices sold in Portugal.


Let MedEnvoy Help You Stay Compliant with European Medical Device and IVD Regulations


As an independent medical device importer for companies exporting to Europe, it's our job to help you maintain compliance with requirements of the European Union, UK and Switzerland. Learn how we can assist.


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