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Table MDR au format Excel
Table IVDR au format Excel
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 :
| Country | Relevant 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 user | Professional 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Belgium | Wet 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)* | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Croatia | Act 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 patients | Croatian 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. | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Cyprus | Cyprus Medical Devices Authority Regulatory Information Ιατρικές Υπηρεσίες(moh.gov.cy) | Greek | Greek or English | Greek or English | Greek or English | Greek or English | Greek or English | Greek | Greek or English | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Law 30 (I)/2002 relating to the Basic Requirements of Certain Categories of Products Basic Requirements (Medical Devices) Regulations 598/2003. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Czech Republic | https://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) | Czech | Czech 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/ZoZPaIVD_AJ%20verze.p df | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Denmark | Executive 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://ww | https://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) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 languagerequirements 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 English | 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). | 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 | 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 IFU | Not specified, but GUI is in general treated similarly to IFU | |||||||||||||||||||||||||||||||||||||||||||||||||||
| determine, based on a risk assessment, which information is necessary for safe use. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| France | 20 April 2022 Ordonnance n° 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) | French | French 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Germany | Gesetz 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/A | N/A | |||||||||||||||||||||||||||||||||||||||||||||||||||
28 April 2020 MPDG.pdf (gesetze-im-internet.de) | language (in justified cases) (§ 8 para 2) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Greece | Directives 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_devices | Hungarian* | Hungarian* | Hungarian* | Hungarian* | Hungarian* | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Ireland | Statutory 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)* | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Latvia | Regulation 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 | 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 explanatio 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* | 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* | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Luxembourg | Grand-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 ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Malta | SUBSIDIARY 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 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 | Regeling 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) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Poland | USTAWA 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 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Portugal | Decree-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. | Portuguese | Portuguese (although English is accepted - current procedure) *The publication of the national legal framework for the MDR is still pending. | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Romania* | 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)* | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Slovakia | Act 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 English | English | language accepted by the NB (mostly SVK or ENG) | Slovak | English has to be explained in the Slovak IFU | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Slovenia | Since the national legislation concerning the Regulations is not | Slovene; | Slovene; | Slovene | Slovene | Slovene | Slovene | Slovene; | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Sweden | Förordning (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 | |||||||||||||||||||||||||||||||||||||||||||||||||||
| requireme | requireme | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| nts |SwedishMedicalProductsAgency(lakemedelsverket.se) | nts |SwedishMedicalProductsAgency(lakemedelsverket.se) | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Iceland | Act 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 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 | Verordnung 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) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Norway | Norwegian (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". | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Turkey | Law 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 ) | Turkish | Turkish or English provided that IFU are presented in Turkish | |||||||||||||||||||||||||||||||||||||||||||||||||||