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Exigences pour les fabricants concernant les traductions

Reglementation des dispositifs medicaux

📣🇪🇺 La Direction générale de la santé et de la sécurité alimentaire vient de publier un "Aperçu des exigences linguistiques pour les fabricants de dispositifs médicaux"


La Commission et les États membres ont créé des tableaux MDR et IVDR . Ces tableaux visent à aider les fabricants de dispositifs médicaux et de dispositifs médicaux de diagnostic in vitro, en particulier ceux de petite et moyenne taille, à comprendre les exigences linguistiques relatives aux informations et instructions qui accompagnent un dispositif dans un pays spécifique. Les tableaux donnent un aperçu des exigences linguistiques pour chaque État membre.

N'oubliez pas pour le Résumé de Sécurité et de Performance Clinique d'un dispositif (SSCP), Art. 32 MDR, vous pouvez vous référer au document d'orientation MDCG-2019-9 Rev.1, qui recommande que le SSCP « soit rédigé d'une manière claire pour l'utilisateur prévu et, le cas échéant, pour le patient (voir MDR, annexe II (2), article 10 (11)), le SSCP doit être traduit dans les langues acceptées dans les États membres où le dispositif est envisagé pour être vendu ».

Pour faciliter la navigation dans les tables, nous les avons converties au format Excel, le lien est disponible en bas de l'article.

Les documents sont très intéressants, voici une copie de ce que vous pouvez trouver pour MDR :

CountryRelevant legal provision (reference and hyperlink to official publication)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 userProfessional
user
    Patient
/lay user
Professio
nal user
Austria* Bundesgesetz betreffend German (§7 para 1)*German or English
(§7 para 1)*
German (§7 para 4)*German (§7 para 2)*German (§7 para 6)*German or English
(§7 para 7 No. 1)*
  
Medizinprodukte 
30 juin 2021 
Medizinproduktegesetz- 2021
BelgiumWet betreffende medische hulpmiddelen 18 January 2021
2020_12_22_Law_on_Medical_Devices.pdf (vbb.com)
French, Dutch and German (Art. 9 para 1)French, Dutch, German or English
(Art. 9 para 1)
French, Dutch, German or English (choice of the patient)
(Art. 13 para 3)
French, Dutch, German or English (Art. 14)French, Dutch and German; in case user is a healthcare professional English is allowed
(Art. 65)
French, Dutch, German or English
(Art. 24)
Considere d as the Label/IFU informatio n:
French, Dutch and German (Art. 9
para 1)
Considere d as the Label/IFU informatio n:
French, Dutch and German or English (Art. 9
para 1)
Bulgaria*LAW ON MEDICAL
DEVICES (bda.bg)
 12 June 2007
Medical devices -Bulgarian Drug Agency(bda.bg)
Bulgarian  (Art. 28 para 2 No. 4)*Bulgarian  (Art. 28 para 2 No. 4)*      
CroatiaAct implementing Regulation (EU) 2017/745 on medical devices and Regulation (EU) 2017/746 on in vitro diagnostic medical devices
22 November 2018 
Zakon.hr
Croatian (Art. 30)Croatian and/or English (declaration/agr eement of professional user needed) (Art. 30). “or” is to be read as without prejudice to Art. 10(p.11) MDR –
information supplied should be clearly comprehensible
to the intended user
Croatian (Art. 30) as the card is intended for patientsCroatian and/or English (Art. 30)Croatian and/or English (Art. 30)Croatian and/or English (Art. 30)Any GUI elements linked to performan ce or safety should follow the same rules as label/IFU.Any GUI elements linked to performan ce or safety should follow the same rules as label/IFU.
CyprusCyprus Medical Devices Authority
Regulatory Information
Ιατρικές            Υπηρεσίες(moh.gov.cy)
GreekGreek or EnglishGreek or EnglishGreek or EnglishGreek or EnglishGreek or EnglishGreekGreek or English
 Law 30 (I)/2002 relating to the Basic Requirements of Certain     Categories     of Products                   Basic Requirements      (Medical Devices)         Regulations 598/2003.        
Czech Republichttps://www.zakonyprolidi.cz/cs/2021-89/zneni-
20210526
Czech
(§8 para 2)
Czech
(§8 para 2)
Czech
(§8 para 2)
Czech, Slovak or English (§8 para 1)Czech
(§ 8 para 2)
Czech, Slovak or English
(§ 8 para 1)
CzechCzech or English
 1 mars 2021        
 375/2022 Sb. Zákon ozdravotnických prostředcích adiagnostických zdravotnickýchprostředcích in vitro(zakonyprolidi.cz)
7 December 2022
        
 https://www.niszp.cz/sites
/default/files/dokumenty/Z
oZPaIVD_AJ%20verze.p df
        
DenmarkExecutive Order no. 837 of 20 June 2023 on Medical Devices etc.
Bekendtgørelse ommedicinsk udstyr m.v.(retsinformation.dk)Language requirement forinformation about medical devices(laegemiddelstyrelsen.dk)
Danish (Chapter II § 3)Danish; English possible upon request (Chapter II § 3 para 2)Danish, exception English
(Chapter II § 4 para 2 )
English,
Danish in specific cases
(Chapter II § 6)
  https://wwhttps://ww
w.retsinformation.d
k/eli/retsin
w.retsinfor
mation.dk/
eli/retsinfo
fo/2021/9840
Danish Guidance, section 2
/2021/984
0 
Danish Guidance, section 2
      Language requireme nt for
informatio
Language requireme nt for
informatio
        n about medical devices(la
egemidde
n about medical devices(la
egemiddel
lstyrelsen.styrelsen.
dk)dk)
Estonia
Medical Devices Act–RiigiTeataja
1 January 2023
Estonian Medical Devices Act available In English: 
https://www.riigiteataja.ee
/en/eli/ee/515032023005/
consolide/current
Labelling and language
requirements for medicaldevices | Governmentinstallation profile (terviseamet.ee)
Estonian (§16 para 3
No.1 and No.3 for custom- made medical devices)
Estonian or English (§16 para 3 No.2)
NB! Language Act § 17 gives the professional user the right to demand information in Estonian.
Estonian or translated into Estonian (§ 324
No. 1)
Estonian or English (§16 para 5)Estonian, initial FSN for urgent cases can be submitted in English (§ 27 (2))Not stated in the national law, but in practice we accept Estonian or EnglishInterpretat ion of the requireme nts in § 16 para 3: no certain requireme nt to translate GUI, but the manufact urer has to assess and establish a suitable way to inform the potential/i ntended user(s).Interpretat ion of the requireme nts in § 16 para 3: no certain requireme nt to translate GUI, but the manufact urer has to assess and establish a suitable way to inform
the potential/i
ntended user(s).
Finland
Laki lääkinnällisistä laitteista 719/2021 (`Medical Devices Act´) 15 July 2021
In English: 
https://www.finlex.fi/en/laki/kaannokset/2021/en202 10719.pdf
Finnish and Swedish (§5)
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. (§5).
*The
manufacturer must
Finnish, Swedish and English
(§5)
Finnish, Swedish or English (§5)To be created in languages which are necessary for safety
(§5)
Finnish, Swedish or English (§5)Not specified, but GUI is in general treated similarly to IFUNot specified, but GUI is in general treated similarly to IFU
   determine, based on a risk assessment, which information is
necessary for safe use.
      
France
Ordinance n° 2022-582
20 April 2022
Ordonnance    2022-582
du  20  avril  2022  portant adaptation       du       droit français     au     règlement (UE)        2017/745        du
Parlement européen et du Conseil  du  5  avril  2017 relatif      aux      dispositifs médicaux    -    Légifrance 
(legifrance.gouv.fr)
(draft decree in progress)
The Use of the FrenchLanguage | economie.gouv.fr
Loi n° 94-665 du 4 août
 1994 relative à l'emploi de la langue française - Légifrance(legifrance.gouv.fr)
French
(Art. R5211-20)
French
(Art. R5211-20)
French (draft decree in progress)French (draft decree in progress)French (draft decree in progress)FrenchFrench based on the general safety and performan ce requireme nts 5 and
22 (no art. in the national law)
French or English based on general requireme nt 5 (no art. in the national law) taking into account the skills and the means available to the users and the influence resulting from variation that can be reasonabl y anticiped in the user’s technique and environm ent
GermanyGesetz zur Durchführung
unionsrechtlicher
German
(§ 8 para 2)
German or
English or users
German
(§ 8 para 3)
German or English
(§ 8 para 1)
German
(§73 para 1)
German or
English (§ 17)
N/AN/A
 Vorschriften betreffend Medizinprodukte
28 April 2020
MPDG.pdf (gesetze-im-internet.de)
 language (in justified cases) (§ 8 para 2)      
GreeceDirectives       90/385/EEC (AIMDD)    &    93/42/EEC (MDD)
national             legislation decrees
ΔΥ8δ/Γ.Π.οικ.        130644 (ΦΕΚ Β’ 2197/2009) &
ΔΥ8δ/Γ.Π.οικ.130648/ (ΦΕΚ Β’ 2198/2009)
Greek
(Art. 4 para 4)
Greek (MDD/AIMDD
Art. 4 para 4)
For MDD,
exceptionally in English (after CA approval)
   Greek and/or another EU language accepted from the NB (MDD Art. 11 para 12 &  AIMDD
Art.9 para 4)
  
Hungary*https://www.ogyei.gov.hu/medical_devicesHungarian*Hungarian*Hungarian* Hungarian*Hungarian*  
IrelandStatutory Instrument No. 547/2017 – EU (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017
8 December 2017
S.I. No. 547 of 2017.
English language or English language and Irish language (No 5 (a))English language or English language and Irish language (No 5 (a))English language or English language and Irish language
(No 5 (a))
English language or English language and Irish language
(No 5 (a))
English language or English language and Irish language (No 5 (a))English language or English language and Irish language (No 5 (a))  
Italy*DECRETO
LEGISLATIVO 5 agosto
2022, n. 137
5 August 2022
Italian (Art. 6)*Italian (Art. 6)*Italian and English (Art. 8)* Italian (Art. 10)*Italian or another EU language accepted by the NB (Art. 11)*  
LatviaRegulation No. 461 of the Cabinet of Ministers of the Republic of Latvia
"Medical Devices Regulations" adopted on 15 August 2023
Official Language Law 28 November 2017
LatvianLatvian 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 explanatio 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
Lithuania*XIII-2754 LietuvosRespublikos sveikatossistemos įstatymo Nr. I-552 2, 3, 16, 59-1, 59-2,
59-3, 59-4, 59-5... (e-
tar.lt)
1 March 2020
Medical devices (underEU directives) | StateAccreditation Service forHealth Care Activitiesunder the Ministry ofHealth (lrv.lt)
Lithuanian*Lithuanian*  Lithuanian*   
LuxembourgGrand-Ducal Regulation of 11 August 1996 on medical devices
https://legilux.public.lu/eli/etat/leg/rgd/1996/08/11/n 12/jo
Grand-Ducal Regulation of 5 February 1993 on
French, German or Luxembourgish (for MD)
(Art. 4 para 4 of
the 1996 regulation)
French or German (for AIMD)
French, German or Luxembourgish or
English (for MD) (Art. 4 para 4 of
the 1996 regulation)
French or
German (for AIMD)
French or German for AIMD
(Art. 4 para 4 of
the 1993 regulation)
French, German or Luxembourgish for MD
French or German and/or a language accepted by the notified body
Art. 9 para 4 of the
1993 regulation)
Art. 9 para 11 of
the 1996 regulation)
French or German for AIMD
(Art. 4 para 4 of
the 1993 regulation)
French, German or
French or German and/or a language accepted by the notified body
Art. 9 para 4 of
the 1993 regulation)
French or German for AIMD
(Art. 4
para 4 of
the 1993 regulation
)
French, German or Luxembo urgish or English (for MD) (Art. 4
para 4 of
the 1996 regulation
)
 active Implantable medical devices
https://legilux.public.lu/eli/etat/leg/rgd/1993/02/05/n 1/jo
medical-devices-EN.pdf
(public.lu)The Luxembourgish legislator expects that the patient or user receive information in a language they understand
(Art. 4 para 4 of
the 1993 regulation)
(Art. 4 para 4 of
the 1993 regulation)
(Art. 4 para 4 of
the 1996 regulation)
 Luxembourgish for MD
(Art. 4 para 4 of
the 1996 regulation)
Art. 9 para 11
of the 1996 regulation)
French, German or Luxembo urgish for MD
(Art. 4
para 4 of
the 1996 regulation
)
French or German (for AIMD) (Art. 4
para 4 of
the 1993 regulation
)
MaltaSUBSIDIARY LEGISLATION 458.59 MEDICAL DEVICES AND IN-VITRO DIAGNOSTIC MEDICAL DEVICES PROVISION ON THE MALTESE MARKET REGULATIONS
4 August 2020
Medicines Authority (gov.mt)
Maltese 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 NetherlandsRegeling medische hulpmiddelen
26 May 2022
BWBR0043450
(overheid.nl)
Dutch
(Art. 1 para 1)
Dutch or English (Art. 1 para 2)Dutch
(Art. 1 para 1)
Dutch or English (Art. 1 para 3)Dutch or English (Art. 1 para 3)Dutch or English (Art. 1
para 3)
  
PolandUSTAWA z dnia 7 kwietnia 2022 r. o wyrobach medycznych
7 April 2022
Polish
(Art. 12 para 1)
Polish or English (Art. 12)Polish (art. 12
para 4)+ art. 12 para 3 ustawa o
prawach pacjenta
Polish – lay user (Art. 12 para 1) English –
professional user
Polish (art. 49
para 3)
Polish or English (Art. 28 para 9)Polish or English but IFU in
Polish
English (art. 12
para 5)
 https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=WDU20220000974  z 6 listopada 2008 r.– https://isap.sejm.gov.pl/isap.nsf/DocDetails.xsp?id=wdu20090520417(Art. 12 para 2)  (art. 12
par. 1, 2) With the exception of devices intended for use in life and health emergenc
ies
 
PortugalDecree-Law 145/2009(tretas.org)
17 June 2009 The national legal
framework for the MDR is still under legislative circuit – this will include language requirements
Portuguese (Art. 5 para 6)Portuguese (Art. 5 para 6)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.
PortuguesePortuguese (although English is accepted - current procedure)
*The publication of the national legal framework for
the MDR is still pending.
  
Romania*http://legislatie.just.ro/Public/DetaliiDocument/2431 91
11 June 2021
Romanian (Art. 3 para 1)*Romanian or English (written consent of healthcare professional needed)
(Art. 3 para 2)*
 Romanian or English (Art. 3 para 7)* Romanian or English (with approval of the CA)*  
SlovakiaAct Nr.362/2011 Coll. onDrugs and Medical Devices
Act Nr. 270/1995 Coll. on Offical Language of the Slovak Republic
Slovak
(Art. 110 b para 1)
Label in ENG if intended for a professional use
Slovak
(Art. 110 b para 1)
Slovak
(Art. 110 b para 1)
Slovak or EnglishEnglishlanguage accepted by the NB (mostly SVK or ENG)SlovakEnglish has to be explained in the Slovak IFU
SloveniaSince the national legislation concerning the
Regulations is not
Slovene;Slovene;SloveneSloveneSlovene SloveneSlovene;
 prepared yet, the Medical Devices act is still in use, from article 33 of Slovenian Medical Devices Act (Official Gazette RS, nr. 98/2009, Zakon o medicinskihpripomočkih (ZMedPri) (pisrs.si); available only in slovene language ):
(5) The instructions for use must be written in the 
Slovene language, legible and understandable for the user, and must contain the date of issue or the date of last revision or amendment. If they have been translated into the Slovene language, the content of the translation must be the same as that of the original package leaflet. If a medical device is intended solely to be used for performing a registered activity (e.g. Professional use), the instructions for use can be written in the language understandable for the user.
The same applies for labelling and packaging.
 For professional use: the instructions for use can be written in the language understandable for the user. (Normally English is acceptable     For profession al use: the instruction s for use can be written in the language understan dable for the user. (Normally English is acceptabl e
Spain Real   Decreto   192/2023, de 21 de marzo, por el que se  regulan  los  productos sanitarios
22 March 2023
 Spanish (art. 5.2)Spanish (art. 5.2)Spanish (art 36.6) Spanish (art 35.6)   
  BOE-A-2023-7416         
SwedenFörordning (2021:631)med kompletterandebestämmelser till EU:sförordningar ommedicintekniskaprodukter | Sverigesriksdag (riksdagen.se)
Language requirements |
Swedish MedicalProducts Agency(lakemedelsverket.se)
Swedish
(3 chapter 1 §)
Swedish
(3 chapter 1 §)
Swedish or English
(3 chapter 1 §, second paragraph)
Swedish or English (3 chapter 2 §)Swedish
(3 chapter 1 §)
Swedish or a language accepted by the notified body
(3 chapter 2 §, second paragraph
See
website Language
See
website Language
requiremerequireme
nts |SwedishMedicalProductsAgency(lakemedelsverket.se)nts |SwedishMedicalProductsAgency(lakemedelsverket.se)
         
IcelandAct on Medical Devices No. 132/2020
8 December 2020
X2020132.dvi
(government.is)
Regulation on IFU with Medical Devices 630/2022
https://island.is/reglugerdir/nr/0630-2022
Icelandic, allowed to be in English or Nordic language except Finnish for class I and IIa
(Art. 12)
Icelandic or English (Art. 12)Icelandic (Art. 19)Icelandic or EnglishIcelandic or EnglishEnglishIcelandic, allowed to be in English or Nordic language except Finnish for class I and IIaIcelandic or English
LiechtensteinVerordnung über den Verkehr mit Medizinprodukten im Europäischen Wirtschaftsraum
27 April 2021
EWR-MepV | Lilex -Gesetzesdatenbank desFürstentum Liechtenstein
German
(Art. 10 para 1)
German or English, if certain requirements are met (Art. 10 para 2)German
(Art. 11 para 1)
German or English (Art. 10 para 4)German
(Art. 10 para 3)
   
          
NorwayMedical DeviceRegulations - Chapter III.Supplementary nationallanguage provisions - LovdataNorwegian (Chapter III Sec. 6)Norwegian (Chapter III Sec. 6)Norwegian (Chapter III Sec. 13)English or Norwegian (Chapter III Sec. 8)Norwegian (Chapter III Sec. 12)English (Chapter III Sec. 7)Norwegia n (Chapter III Sec. 6)
Except: Symbols such as "On",
"Off",
"Load",
"Enter", "Page up".
Norwegia n (Chapter III Sec. 6)
Except: Symbols such as "On",
"Off",
"Load",
"Enter", "Page up".
TurkeyLaw No. 7223 on ProductSafety and TechnicalRegulations
Dated 02.06.2021 and
numbered 31499 
Medical Device Regulation (TR-MDR)
Circular No. 2022/1 onmedical devices
Turkish
(TR-MDR Art 10
para 11)  and
Law No. 7223 Art 7 (1)(ğ) )
Turkish
( TR- MDR Art
10 para 11 and
Law No. 7223 Art para 7 (1)(ğ)
)
Exception: Label may be in English (with approval of the CA) in accordance with Section E, point 2 of Circular No. 2022/1
Turkish  and,  if necessary,
English
( TR-MDR Art 18
para 2)
Turkish
( TR-MDR Art 19
para 1)
Turkish
(TR-MDR Art 87
para 8(a) )
Turkish
(TR-MDR Art
52 para 11 )
TurkishTurkish or English provided that IFU are presented in Turkish
Source Table MDR au format Excel Table IVDR au format Excel