Language requirements for Manufacturers – Europe
Different legal provisions outlined in Regulation (EU) 2017/745 on medical devices (MDR) permit Member States to establish national language requirements for makers of device companion materials. If Member States have taken advantage of the opportunity to establish language requirements for manufacturers, the following table provides an overview of the national rules. It is optional for Member States to choose a single language.
The below information is provided based on the information available to the Commission services following a consultation of the Medical Device Coordination Group (MDCG) in October 2023.
| Country | Label/IFU (Art. 10 (11), Annex I, section 23, MDR) | Implant card (Art. 18 (I) MDR) | Declaration of conformity (Art 19 (I) MDR) | Field safety notice (Art. 89 (8) MDR) | Documents for conformity assessment (Art. 52 (12) | (Graphic) user interface (e.g. Apps) | ||
|---|---|---|---|---|---|---|---|---|
| Patient/lay user | Professional user | Patient/lay user | Professional user | |||||
| Austria | German | German or English | German | German | German | German or English | ||
| Belgium | French, Dutch and German | French, Dutch, German or English | French, Dutch, German or English (choice of the patient) | French, Dutch, German or English | French, Dutch and German; in case user is a healthcare professional English is allowed | French, Dutch, German or English | Considered as the Label/IFU information: French, Dutch and German | Considered as the Label/IFU information: French, Dutch and German or English |
| Bulgaria | Bulgarian | Bulgarian | ||||||
| Croatia | Croatian | Croatian and/or English (declaration/agr eement of professional user needed). “or” is to be read as without prejudice information supplied should be clearly comprehensible to the intended user | Croatian as the card is intended for patients | Croatian and/or English | Croatian and/or English | English | elements linked to performance or safety should follow the same rules as label/IFU. | linked to performance or safety should follow the same rules as label/IFU |
| Cyprus | Greek | Greek or English | Greek or English | Greek or English | Greek or English | Greek or English | Greek | Greek or English |
| Czech Republic | Czech | Czech | Czech | Czech, Slovak or English | Czech | Czech, Slovak or English | Czech | Czech or English |
| Denmark | Danish | Danish; English possible upon request | Danish, exception English | Danish | Danish | |||
| Estonia | Estonian | Estonian or English | Estonian or translated into Estonian | Estonian or English | Estonian, initial FSN for urgent cases can be submitted in English | Not stated in the national law, but in practice we accept Estonian or English | Interpretation of the requirement nts: no certain requirement to translate GUI, but the manufacturer has to assess and establish a suitable way to inform the potential/intended user(s). | Interpretation of the requirement nts : no certain requirement to translate GUI, but the manufacturer has to assess and establish a suitable way to inform the potential/intended user(s). |
| Finland | Finnish and Swedish For Custom made MD: Finnish or Swedish, or both, depending on patient/customer need. | Finnish, Swedish or English.However, information necessary for ‘safe use’* must be in Finnish and Swedish.The Manufacturer must determine, based on a risk assessment, which information is necessary for safe use. | Finnish, Swedish and English | Finnish, Swedish or English | To be created in languages which are necessary for safety | Finnish, Swedish or English | Not specified, but GUI is in general treated similarly to IFU | Not specified, but GUI is in general treated similarly to IFU |
| France | French | French | French | French | French | French | French based on the general safety and performan ce requirements | French or English based on general requireme nt taking into account the skills and the means available to the users and the influence resulting from variation that can be reasonably anticiped in the user’s technique and environment |
| Germany | German | German or English or users | German | German or English | German | German or English | N/A | N/A |
| Greece | Greek | Greek For MDD,exceptionally in English (after CA approval) | Greek and/or another EU language accepted from the NB | |||||
| Hungary | Hungarian | Hungarian | Hungarian | Hungarian | Hungarian | |||
| Ireland | English language or English language and Irish language | English language or English language and Irish language | English language or English language and Irish language | English language or English language and Irish language | English language or English language and Irish language | English language or English language and Irish language | ||
| Italy | Italian | Italian | Italian and English | Italian | Italian or another EU language accepted by the NB | |||
| Latvia | Latvian | Latvian or English if a medical device is intended to be used only in a health care facility and a consent of the health care facility is provided regarding use the foreign language | Latvian | Latvian | Latvian | Latvian | Latvian or English if an explanation n of functions is available in the IFU | Latvian or English if a device is intended to be used only in a health care facility and a consent of the health care facility is Provided |
| Lithuania | Lithuanian | Lithuanian | Lithuanian | |||||
| Luxembourg | French, German or Luxembourgish(for MD)French or | French, German or Luxembourgish or English (for MD) French or German (for AIMD) | French or German for AIMD French, German or Luxembourgish for MD | French or German and/or a language accepted by the notified body | French or German for AIMD French, German or Luxembourgish for MD | French or German and/or a language accepted by the notified body | French or German for AIMD | French, German or Luxembourgish or English French or German (for AIMD) |
| Malta | Maltese and/or English | Maltese and/or English | Maltese and/or English | Maltese and/or English | Maltese and/or English | Maltese and/or English | Maltese and/or English | Maltese and/or English |
| The Netherlands | Dutch | Dutch or English | Dutch | Dutch or English | Dutch or English | Dutch or English | ||
| Poland | Polish | Polish or English | Polish | Polish – lay user English – professional user | Polish | Polish or English | Polish or English but IFU in Polish With the exception of devices intended for use in life and health emergencIes | English |
| Portugal | Portuguese | Portuguese | Portuguese The publication of the national legal framework for the MDR is still pending. | Portuguese (although English is accepted – current procedure) The publication of the national legal framework for the MDR is still pending. | Portuguese | Portuguese (although English is accepted – current procedure) The publication of the national legal framework for the MDR is still pending. | ||
| Romania | Romanian | Romanian or English (written consent of healthcare professional needed) | Romanian or English | Romanian or English (with approval of the CA) | ||||
| Slovakia | Slovak Label in ENG if intended for a professional use | Slovak | Slovak | Slovak or English | English | language accepted by the NB (mostly SVK or ENG) | Slovak | English has to be explained in the Slovak IFU |
| Slovenia | Slovene | Slovene For professional u se: the instructions for use can be written in the language understandable for the user. (Normally English is acceptable | Slovene | Slovene | Slovene | Slovene | Slovene; For profession al use: the instruction s for use can be written in the language understan dable for the user. (Normally English is acceptable | |
| Spain | Spanish | Spanish | Spanish | Spanish | ||||
| Sweden | Swedish | Swedish | Swedish or English | Swedish or English | Swedish | Swedish or a language accepted by the notified body | ||
| Iceland | Icelandic, allowed to be in English or Nordic language except Finnish for class I and IIa | Icelandic or English | Icelandic | Icelandic or English | Icelandic or English | English | Icelandic, allowed to be in English or Nordic language except Finnish for class I and IIa | Icelandic or English |
| Liechtenstein | German | German or English, if certain requirements are met | German | German or English | German | |||
| Norway | Norwegian | Norwegian | Norwegian | English or Norwegian | Norwegian | English | Norwegian | Norwegian |
| Turkey | Turkish | Turkish Exception: Label may be in English (with approval of the CA) | Turkish and, if necessary,English | Turkish | Turkish | Turkish | Turkish | Turkish or English provided that IFU are presented in Turkish |
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