The new EU Medical Devices Regulation has introduced more stringent language requirements for medical devices sold in the EU market. In doing so, it has placed the responsibility on each EU Member State to determine the language(s) in which the information related to the device is provided. In this article, we’ll outline which languages are accepted in individual EU Member States in response to these MDR language requirements.
Following on from our previous article on the language requirements for medical devices sold in the EU market under the new EU Medical Devices Regulation (MDR 2017/745/EU), we’ll now focus on their practical implications across the individual EU Member States. Under the MDR, the information intended for the patient and/or the user supplied with a medical device must be provided in one or more official language(s) of the EU. Each EU Member State determines which official language(s) must be used in that State.
What is the practical purpose of the MDR language requirements?
The MDR’s single most important objective is patient safety. The purpose of the MDR language requirements is to contribute to the achievement of this objective by ensuring all information supplied with the device is fully understood by its intended reader.
This is guaranteed by means of:
- • the choice of the official language(s) that the reader fully comprehends; and
- • the level of technical detail that the reader is reasonably expected to be comfortable with in that language (based on the reader’s technical knowledge, experience, and training).
EU Member States are therefore expected not only to determine which language(s) they accept, but also to specify what type of information can be presented in each language.
For more in-depth discussion of why it’s essential that the reader understands information supplied with a medical device, please read our article ‘Why Technical Document Localisation is Key to the Optimal Performance and Safety of Your Medical Device’.
Let’s start with explaining what the official languages of the EU are.
What are the official languages of the EU?
The EU has 24 official languages. These are: Bulgarian, Croatian, Czech, Danish, Dutch, English, Estonian, Finnish, French, German, Greek, Hungarian, Irish, Italian, Latvian, Lithuanian, Maltese, Polish, Portuguese, Romanian, Slovak, Slovene, Spanish, and Swedish. Of these, English, French, and German have the higher status of procedural languages in the European Commission and in the day-to-day working of the EU institutions. The European Parliament accepts all official languages of the EU as working languages.
In addition, Irish has received three subsequent five-year periods of derogation as an official language of the EU, but as of 1st January 2022, it will enjoy full language status in line with the other official and working languages of the EU institutions.
Also, several EU Member States have their own official or co-official languages which don’t have the status of an official language of the EU. A prominent example is Spain, with Spanish as its official language and also an official language of the EU, and four co-official regional languages which aren’t official languages of the EU. Luxembourgish is an official language of Luxembourg, alongside French and German, but it isn’t recognised as an official language of the EU. Similarly, Turkish has the status of an official languages of Cyprus, alongside Greek, but isn’t an official language of the EU. Luxembourgish and Turkish are the only two official nationwide languages of EU Member States that aren’t official languages of the EU.
For the purpose of the MDR language requirements, the official languages of the EU are the 24 languages listed above.
Why might different languages be selected for information intended for the patient and the information intended for the professional user?
As briefly explained earlier, each EU Member State is expected to select a language(s) that is easily understood by the intended reader in that State. For the patient, that language will almost always be the official language(s) of the EU Member State where they live, which will most likely be their native language (or at least their language of habitual use). This is to ensure that the patient fully understands how to use the device safely and efficiently.
However, some EU Member States allow certain exceptions for medical devices intended exclusively for healthcare professionals. In these cases, the professional users are expected to be sufficiently proficient in the selected foreign language(s) — typically English — to be able to fully understand the information provided with the device. The benefit of these exceptions is that they eliminate the need to have the information translated. This reduces the time and costs required to bring the device to the market.
For more practical advice on translating information related to medical devices, please see our recent articles ‘How to Prepare Your Document for a Medical Device Translation Project’ and ‘How to Optimise Technical Document Translation for Your New Export Markets’.
Which languages are accepted in individual EU Member States in response to the MDR language requirements?
The Table below presents the languages accepted in individual EU Member States in line with the MDR language requirements.
| EU Member State | For Patient | For Professional User |
|---|---|---|
| Austria | German | German; English is acceptable* |
| Belgium | French and Dutch and German | English is acceptable; French or Dutch or German upon user’s request* |
| Bulgaria | Bulgarian | Bulgarian |
| Croatia | Croatian | Croatian and/or English |
| Cyprus | Greek | Greek or English |
| Czech Republic | Czech | Czech |
| Denmark | Danish, exceptions allowed* | Danish, exceptions allowed* |
| Estonia | Estonian | Estonian, exceptions allowed* |
| Finland | Finnish and Swedish | Finnish or Swedish or English, conditions apply* |
| France | French | French |
| Germany | German | German or English or another language, conditions apply* |
| Greece | Greek | Greek |
| Hungary | Hungarian | Hungarian |
| Ireland | English or English and Irish | English or English and Irish |
| Italy | Italian | Italian |
| Latvia | Latvian | Latvian |
| Lithuania | Lithuanian | Lithuanian |
| Luxembourg | French or German or Luxembourgish | French or German or Luxembourgish or English |
| Malta | Maltese or English | Maltese or English |
| Netherlands | Dutch | Dutch or English, conditions apply* |
| Poland | Polish | Polish or English |
| Portugal | Portuguese | Portuguese |
| Romania | Romanian | Romanian |
| Slovakia | Slovak | Slovak |
| Slovenia | Slovene | Slovene, exceptions allowed* |
| Spain | Spanish | Spanish |
| Sweden | Swedish | Swedish |
Disclaimer: Please note that the information provided in this Table is for reference only, and based on both official and unofficial translations. Therefore, the original legally binding language version should always be used. In case of any doubt, the competent authority from the relevant EU Member State must be consulted. All details correct at the time of publication.
In this article, we focus exclusively on the information supplied with a medical device that is intended for the patient and/or user. Therefore, please be aware that each EU Member State may have a different set of guidelines for technical documentation, such as the declaration of conformity. For example, in the Czech Republic, the State Institute for Drug Control can receive such a declaration in Czech or Slovak or English.
Where can we find more detailed information?
If you’d like more detailed information on the languages accepted in individual EU Member States under the MDR language requirements, please download the extended version of the Table here. It includes summaries of national legislation with links to the official sources.
Table updated: March 2022