Under the Medical Devices Directive (MDD), it is required that manufacturers have translations of the technical documents like Instructions for Use. However, this rule wasn’t strictly followed up until MDR was brought in place.
The European Union’s language requirements information can be found in Article 41 and Annex 1 (Chapter 3) of the EU MDR.
Language requirements: EU Requirements for Translations
As per MDR 2017/745, the information provided with medical devices needs to be translated into different languages. The EU requirements for Translations mainly affects the computer software, labelling, instructions for use and packaging instructions.
Norway and Belgium have already implemented the language requirements for their country.
Although this is an additional requirement for device manufacturers, it makes understanding easier for the end-users. The MDR also makes a mandatory requirement to supplement translated texts with internationally recognized symbols and drawings to simplify user learning.
Further information on accepted symbols can be found in our article on Symbols used in labelling.
Read more about this topic here: EU MDR language requirements.
Officially recognized languages
The table below shows the different countries with the European Union and the official languages. Some countries also accept English but having multiple accepted language translations is mandatory under the new regulation.
| COUNTRY | MDR LANGUAGE ACCEPTED | LANGUAGE COUNTRY CODE (FOR LABELING) |
| Austria, Germany, Belgium*, Luxembourg | German | DE |
| Belgium*, Luxembourg*, France | French | FR |
| Ireland, Malta | English | EN |
| Belgium*, Netherlands | Dutch | NL |
| Greece, Cyprus | Greek | EL |
| Bulgaria | Bulgarian | BG |
| Croatia | Croatian | HR |
| Czechia | Czech | CS |
| Denmark | Danish | DA |
| Estonia | Estonian | ET |
| Finland | Finnish | FI |
| Hungary | Hungarian | HU |
| Italy | Italian | IT |
| Latvia | Latvian | LV |
| Lithuania | Lithuanian | LT |
| Poland | Polish | PL |
| Portugal | Portuguese | PT |
| Romania | Romanian | RO |
| Slovakia | Slovak | SK |
| Slovenia | Slovenian | SL |
| Spain | Spanish | ES |
| Sweden | Swedish | SV |
| Cyprus | Turkish | TR |
Indicates countries with multiple official languages
Why choose our translation services?
It is crucial to select a translation agency that understands the various translation requirements. OMC is an ISO accredited company. We have a team of language experts with experience in the medical device industry.
Therefore, we provide a consistent and quality output each time.
For more information on our translation service, please mail us at info@omcmedical.co.uk.
