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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.

CountryLabel/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 userProfessional user    Patient/lay userProfessional user
AustriaGermanGerman or EnglishGermanGermanGermanGerman or English  
BelgiumFrench, Dutch and GermanFrench, Dutch, German or EnglishFrench, Dutch, German or English (choice of the patient)French, Dutch, German or EnglishFrench, Dutch and German; in case user is a healthcare professional English is allowedFrench, Dutch, German or EnglishConsidered as the Label/IFU information:
French, Dutch and German
Considered as the Label/IFU information:
French, Dutch and German or English
BulgariaBulgarianBulgarian      
CroatiaCroatianCroatian 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 patientsCroatian and/or EnglishCroatian and/or EnglishEnglishelements 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
CyprusGreekGreek or EnglishGreek or EnglishGreek or EnglishGreek or EnglishGreek or EnglishGreekGreek or English
Czech RepublicCzechCzechCzechCzech, Slovak or EnglishCzechCzech, Slovak or EnglishCzechCzech or English
DenmarkDanishDanish; English possible upon requestDanish, exception English   DanishDanish
EstoniaEstonianEstonian or EnglishEstonian or translated into EstonianEstonian or EnglishEstonian, initial FSN for urgent cases can be submitted in EnglishNot stated in the national law, but in practice we accept Estonian or EnglishInterpretation 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).
FinlandFinnish 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 EnglishFinnish, Swedish or EnglishTo be created in languages which are necessary for safetyFinnish, Swedish or EnglishNot specified, but GUI is in general treated similarly to IFUNot specified, but GUI is in general treated similarly to IFU
FranceFrenchFrenchFrenchFrenchFrenchFrenchFrench based on the general safety and performan ce requirementsFrench 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
GermanyGermanGerman or English or usersGermanGerman or EnglishGermanGerman or EnglishN/AN/A
GreeceGreekGreek For MDD,exceptionally in English (after CA approval)   Greek and/or another EU language accepted from the NB  
HungaryHungarianHungarianHungarian HungarianHungarian  
IrelandEnglish language or English language and Irish languageEnglish language or English language and Irish languageEnglish language or English language and Irish languageEnglish language or English language and Irish languageEnglish language or English language and Irish languageEnglish language or English language and Irish language  
ItalyItalianItalianItalian and English ItalianItalian or another EU language accepted by the NB  
LatviaLatvianLatvian 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 languageLatvianLatvianLatvianLatvianLatvian or English if an explanation n of functions is available in the IFULatvian 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
LithuaniaLithuanianLithuanian  Lithuanian   
LuxembourgFrench, German or Luxembourgish(for MD)French orFrench, German or Luxembourgish or English (for MD) French or German (for AIMD)French or German for AIMD French, German or Luxembourgish for MDFrench or German and/or a language accepted by the notified bodyFrench or German for AIMD French, German or Luxembourgish for MDFrench or German and/or a language accepted by the notified bodyFrench or German for AIMDFrench, German or Luxembourgish or English French or German (for AIMD)
MaltaMaltese and/or EnglishMaltese and/or EnglishMaltese and/or EnglishMaltese and/or EnglishMaltese and/or EnglishMaltese and/or EnglishMaltese and/or EnglishMaltese and/or English
The NetherlandsDutchDutch or EnglishDutchDutch or EnglishDutch or EnglishDutch or English  
PolandPolishPolish or EnglishPolishPolish – lay user English – professional userPolishPolish or EnglishPolish or English but IFU in Polish With the exception of devices intended for use in life and health emergencIesEnglish
PortugalPortuguesePortuguesePortuguese 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.PortuguesePortuguese (although English is accepted – current procedure) The publication of the national legal framework for the MDR is still pending.  
RomaniaRomanianRomanian or English (written consent of healthcare professional needed) Romanian or English Romanian or English (with approval of the CA)  
SlovakiaSlovak Label in ENG if intended for a professional useSlovakSlovakSlovak or EnglishEnglishlanguage accepted by the NB (mostly SVK or ENG)SlovakEnglish has to be explained in the Slovak IFU
SloveniaSloveneSlovene For professional u se: the instructions for use can be written in the language understandable for the user. (Normally English is acceptableSloveneSloveneSlovene SloveneSlovene; For profession al use: the instruction s for use can be written in the language understan dable for the user. (Normally English is acceptable
SpainSpanishSpanishSpanish Spanish   
SwedenSwedishSwedishSwedish or EnglishSwedish or EnglishSwedishSwedish or a language accepted by the notified body  
IcelandIcelandic, allowed to be in English or Nordic language except Finnish for class I and IIaIcelandic or EnglishIcelandicIcelandic or EnglishIcelandic or EnglishEnglishIcelandic, allowed to be in English or Nordic language except Finnish for class I and IIaIcelandic or English
LiechtensteinGermanGerman or English, if certain requirements are metGermanGerman or EnglishGerman   
NorwayNorwegianNorwegianNorwegianEnglish or NorwegianNorwegianEnglishNorwegianNorwegian
TurkeyTurkishTurkish Exception: Label may be in English (with approval of the CA)Turkish and, if necessary,EnglishTurkishTurkishTurkishTurkishTurkish or English provided that IFU are presented in Turkish

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