Language requirements for Manufacturers – Europe

February 13, 2024 | Regulatory Information Management

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)
Country	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