For which market(s) would like like to see the requirements?

Austria

Is additional registration required: No – only local Economic Operators have registration obligations

Helpful Links:

• Registration Requirements

Belgium

Professional Use: English, but professional user may require that manufacturer provides the information in the national language of their choice, i.e., the manufacturer may be required provide information in French, Dutch or German.

Regulation: Law relating to medical devices

Article 9. § 1. Pursuant to Article 10(11) of the regulation 2017/745, the manufacturers support the devices made available to the user or patient on the Belgian territory of the information referred to in Annex I, section 23, of Regulation 2017/745 in the three national languages. By way of exception, for devices whose users are exclusively healthcare professionals, this information may be provided in English. In this case, however, the user may require the manufacturer to provide this information in the national language of their choice.

Bulgaria

Professional Use: Bulgarian

Citation: Medical Devices Act

Article 16 (3) The instruction for use shall also be written in Bulgarian language.

Croatia

Professional Use: Croatian and/or English

Citation: Act on the Implementation of Medical Devices Regulation (EU) 2017/745 and In Vitro Medical Device Regulation (EU) 2017/746 (Official Gazette No. 100/18)

Article 30: (1) Data and documentation used in the implementation of the regulations referred to in Article 2 of this Act, and intended for patients and lay people, must be in the Croatian language. (2) Data and documentation used in the implementation of the regulations referred to in Article 2 of this Act, and intended for the competent authorities or exclusively for use in the performance of health care activities, may be in Croatian and / or English.

Cyprus

Professional Use: Greek or English

Citation: Requirements for the placement of Medical Devices in the Cypriot Market

We also inform you that the Competent Authority of Medical Equipment of Cyprus accepts Greek as the official language for products intended to be used by non-health professionals, while for products intended for health professionals the English language is also acceptable.

Czech Republic

Professional Use: Czech

Citation: Act No. 89/2021 Coll., on Medical Devices and on Amendment to Act No 378/2007 Coll., on Pharmaceuticals and on Amendments to Some Related Acts (Act on Pharmaceuticals)

Section 8. (2) The manufacturer shall be obliged to provide the information referred to under Art. 10(11) of the Medical Device Regulation and information listed under Art. 18(1)(a) to (d) of the Medical Device Regulation in the Czech language.

Denmark

Professional Use: Danish, with possible exemptions

Citation: Executive order no. 957 of 29 April 2021 on medical devices and products without a medical purpose (in Danish only)

3. The marking and instructions for use of an equipment must be written in Danish when the equipment is made available to the end user or patient in Denmark, 2. The Danish Medicines Agency may exceptionally allow the information on the label and in the instructions for use not to be written in Danish.

Estonia

Professional Use: Estonian

Citation: Estonia's 2004 Medical Devices Act

(3) The information strictly necessary for the safe use of a medical device for its intended purpose accompanying a medical device to be placed on the market, distributed and put into service in Estonia shall be presented in the Estonian language and in an appropriate manner, taking account of the knowledge of the potential user of the device. The remaining information accompanying a device may be presented in another language of a Member State of the European Economic Area understandable to the potential user.

Finland

Professional Use: Finnish and Swedish. Exception may be possible for single-use devices (see regulation excerpt below)

Citation: Medical Devices Act (719/2021)

Section 5: Requirements for the language to be used - the information and documents referred to in Article 10(11) of the MD Regulation and in Article 10(10) of the IVD Regulation must be in Finnish, Swedish or English, unless the information is provided in the form of internationally recognised symbols. Information necessary for the safe use of a device must, however, be available in Finnish and in Swedish. The manufacturer must determine, based on a risk assessment, which information is necessary for safe use. If a device is intended for use by patients or other consumers, instructions for use and other information necessary for safe use must be available in Finnish and in Swedish. The instructions for use and labels of single-use devices referred to in the MD Regulation must be either in Finnish or in Swedish or in both languages, depending on the user’s needs.

France

Professional Use: French

Citation: Decree no. 95-292 of March 16, 1995 relating to the medical devices defined in article L. 665-3 of the public health code and modifying this code (second part: Decrees in Council of State)

Item R5211-20, The labeling of a medical device given to the end user or the patient, the leaflet that accompanies it, as well as any other information relating to its functioning or its use include a version written in French.

Germany

Professional Use: German, with possible exemptions

Citation: Medical Devices EU Adaptation Act – MPEUAnpG Medical Device Law Implementation Act (MPDG)

§ 8th language regime for the EU Declaration of Conformity and for product information: (1) The manufacturer has made available on the market for products within the scope of this Act the EU declaration of conformity according to Article 19 Paragraph 1 of Regulation (EU) 2017/745 in German or to be made available in English. (2) Within the scope of this Act, products may only be sold to users and patients if the users and patients certain information in German will be provided. In justified cases, the information may also be in English or another for the user of the medical device easy-to-understand language provided if this information is solely for professional users are intended and the safety-related information is also available in German or in the language of the user be asked. (3) The manufacturer of an implantable device has the information according to Article 18 paragraph 1 subparagraph 1 of Regulation (EU) 2017/745 in German to provide language.

Greece

Professional Use: Greek, with possible exemptions

Citation: Ministerial Decision ΔΥ8δ / Γ.Π.οικ. / 130648/2009 - ΦΕΚ 2198 / B / 2-10-2009

Article 4 (4) The information that must be available to the user and the patient according to Annex I point 13, must be complete and accurate in the Greek language, upon delivery to the end user, whether it is for professional use or another. Any contraindications or side effects should be clearly stated. The EOF may, by way of derogation from the provisions of this Decision, decide on a case-by-case basis, for products intended exclusively for professional use, the exemption from the mandatory use of the Greek language in the information in Annex I, point 13, taking into account the principle of proportionality and in particular the possibility of indicating such indications by means of harmonized or recognized symbols or other measures, as well as the intended use of the product. In this case it is mandatory to indicate this information in English.

Hungary

Professional Use: Hungarian

Citation: Hungarian National Institute of Pharmacy and Nutrition Website

The essential requirements (e.g. language requirements, etc.) should be fulfilled according to the relevant Hungarian decree. If the product is available on the Hungarian market, the IFU and label of medical devices and IVD medical devices must be available in Hungarian.

Iceland

Professional Use: Icelandic not required, but education level of user should be considered

Citation: Icelandic Medicines Agency Website

Medical devices that patients themselves must operate should include the required instructions and labelling in Icelandic. This requirement does not apply to medical devices operated by healthcare professionals but should take into account their education and training.

Ireland

Professional Use: English

Citation: S.I. No. 547/2017 - European Union (Medical Devices and In Vitro Diagnostic Medical Devices) Regulations 2017

5. For the purposes of— (a) Articles 10(11) and (14), 11(3)(d), 18(1), 19(1), 41, 52(12), 56 and 89(8) of Regulation (EU) 2017/745, and (b) Articles 10(10) and (13), 11(3)(d), 17(1), 37, 48(11), 51 and 88(8) of Regulation (EU) 2017/746, the language determined by the State is the English language or both the Irish language and the English language.

Italy

Professional Use: Italian

Citation: ATTUAZIONE DELLA DIRETTIVA 93/42/CEE CONCERNENTE I DISPOSITIVI MEDICI (Legislative Decree of 24.02.1997 n. 46, implementing Directive 93/42/EEC(Art 5))

Article 5 (4.) The directions, provided by the manufacturer to the user and to the patient in accordance with Annex I, point 13, are expressed in Italian at the time of delivery to the end user, for professional use or for any other use.

Latvia

Professional Use: Latvian

Citation: Press Release - May 26, 2021 - State Agency of Medicines

When medical devices are purchased, they must be accompanied by the instructions for use in the official language and must contain all the information necessary for their safe and proper use and for the manufacturer.

Lithuania

Professional Use: Lithuanian

Citation: Lithuanian State Health Care Accreditation Agency Website

At the point when the device reaches the final user, irrespective of the users competence (professional or not), all information supplied by the manufacturer (label, instructions for use) must be in Lithuanian language.

Lichtenstein

Professional Use: German or English (if all below criteria specified in regulation is met)

Citation: Liechtenstein State Law Gazette No. 161

Article 10, Defining the language - 1) The labeling and the instructions for use (product information) according to Art. 10 Para. 11 of Regulation (EU) 2017/745 must be written in German. Symbols that are specified by technical standards can replace verbal statements. 2) Deviating from paragraph 1, the product information can be written in English, provided that: a) the product is only given to professionals or the product is a custom-made product or a product manufactured and used in a healthcare facility; b) it is ensured that the user has the necessary technical and linguistic requirements and agrees to the writing in English; c) the protection of patients, users and third parties is guaranteed; and d) the effective and performance-related application is not jeopardized.

Luxembourg

Professional Use: French, German or Luxembourgish

Citation: DISPOSITIFS MEDICAUX

Article 4 - 4. The information which must be provided to the user and the patient in accordance with point 13 of Annex I must be written in one of the French, German or Luxembourgish languages when delivered to the end user, whether either for professional or other use. When the device is exclusively intended for professional use, these indications may also be written in English.

Malta

Professional Use: Maltese or English

Citation: SUBSIDIARY LEGISLATION 427.44 - MEDICAL DEVICES REGULATIONS

5. (11) When a device reaches the final user, regardless of whetherit is for professional or other use, the information which must bemade available to the user and the patient in accordance with section 13 of Schedule I, shall be provided in, at least, the Maltese or English language

Netherlands

Professional Use: Dutch or English (if below criteria are met)

Citation: Medical Devices Regulation

Article 1 - Language requirements: 1. The information and general summary referred to in Articles 10, paragraph 11, 18, paragraph 1, second subparagraph, and Annex XV, Chapter II, point 3.1.5 of Regulation (EU) 2017/745 and 10, paragraph 10, of Regulation (EU) 2017/746, are drawn up in the Dutch language. 2. By way of derogation from the first paragraph, the information referred to in Article 10, paragraph 11, of Regulation (EU) 2017/745 and Article 10, paragraph 10, of Regulation (EU) 2017/746 may be drawn up in the English language, insofar as the medical device or medical device for in vitro diagnostics is intended to be used exclusively by a healthcare provider and on the condition that the healthcare provider has an adequate command of the English language.

Norway

Professional Use: Norwegian, with possible exemptions

Citation: Regulations on medical equipment

§ 8. § 8. Labeling and instructions for use - Information on the label and in the instructions for use of medical equipment must be given in Norwegian, cf. regulation (EU) 2017/745 (MDR) article 10 no. 11 and regulation (EU) 2017/746 (IVDR) article 10 no. 10. § 17. Exceptions - If safe and correct use is ensured, the Norwegian Medicines Agency can make exceptions to the Norwegian language requirement in section 8.

Poland

Professional Use: Polish or English with healthcare provider’s written consent

Citation: Act of 7 April 2022 on Medical Devices (the "Act")

Polish language requirement for product markings and instructions 1. Products intended for use in the territory of the Republic of Poland have markings and instructions for use in Polish or expressed with harmonized symbols or recognizable codes. 2. It is allowed for devices intended for use in the territory of the Republic of Poland to be provided to healthcare providers, with their written consent, to have markings or instructions for use in English, with the exception of information intended for the patient, which is given in Polish or expressed with harmonized symbols or recognizable symbols. codes.

Portugal

Professional Use: Portuguese

Citation: Decree-Law n.º 145/2009, of June 17th

Article 5 (6) - The labeling and instructions for use of any devices must be written in Portuguese and comply with the provisions of paragraph 13 of Annex I of the present decree-law, of which it forms an integral part, or, in the case of provisions active implantable doctors, in numbers 17, 18 and 19 of annex x of this decree-law, of which it forms an integral part, regardless of whether or not they are intended for a professional use.

Romania

Professional Use: Romanian

Citation: Government Decision no. 54 of 29 January 2009 on conditions for placing on the market of medical devices, as amended

ART 11.(4) When a device reaches the end user, whether or not the device is in use professionally, the information provided in point 13 of annex no. 1, provided to the user and patient, must be written in Romanian.

Slovakia

Professional Use: Slovakian

Citation: State Institute for Drug Control Website - FAQ Page

6. Must the marking of the device (label) and instructions for use for the medical device from a foreign manufacturer be in the Slovak language? Yes, this obligation results from § 110b paragraph 1 of Act No. 362/2011 Coll. and § 2 paragraph 2 of Government Regulation No. 569/2001 Coll.

Slovenia

Professional Use: Slovenian, with possible exemptions

Citation: Medical Devices Act (Official Gazette of the Republic of Slovenia, No. 98/09)

Article 33 (5) Instructions for use must be written in the Slovenian language, legible and user-friendly, and must contain the date of issue or the date of the last correction or amendment. If they are translated into Slovenian, the content of the translation must be the same as the original instructions for use. If the medical device is intended exclusively for use in the performance of activities entered in a court or business register, the instructions for use may be written in a user-friendly language.

Spain

Professional Use: Spanish

Citation: INFORMATION ON THE REGULATION IN SPAIN OF MEDICAL DEVICES (Summary updated on 03-21-2010)

LABELING OF MEDICAL DEVICES - The labeling of medical devices consists of the label and the instructions for use. The data that must appear on the label will comply with the provisions of point 13 of Annex I. The name and address of the manufacturer and, when the manufacturer is not in the European Union, the name and address of the authorized representative in the European Union must also appear on the label or in the instructions for use. At the time of distribution in Spain, the labeling of the products must appear in Spanish, as established in article 4.

Sweden

Professional Use: Swedish, with possible exemptions

Citation: Regulation (2021: 631) with supplementary provisions to EU regulations on medical devices

Chapter 3 Labeling, information and documentation Section 1 - The information referred to in Articles 18 (1) and 89 (8) and in section 23 of Annex I to Regulation (EU) 2017/745 and the information referred to in Article 84 (8) and section 20 of Annex I to Regulation (EU) 2017/746 shall be in Swedish when a product is provided to users or patients in Sweden, regardless of whether it is intended for professional or other use.

Switzerland

Professional Use: Italian, French and German, exceptions noted in regulation excerpt below

Citation: Medical Devices Ordinance (MedDO) of 1 July 2020 (Status as of 26 May 2021)

Art. 16 Product information – 1. Product information comprises the labelling and instructions for use. It is governed by Chapter III of Annex I to EU-MDR23. 2. It must be written in all three official languages of Switzerland. Symbols established by means of technical standards may be used to replace written statements. 3. The product information may be provided in fewer than the three official languages of Switzerland or in English, provided that: a. the device is supplied exclusively to professionals or is a custom-made device or a medical device manufactured and used in a healthcare institution; b. it is certain that the user meets the necessary professional and linguistic requirements and qualifications, and is in agreement; c. the protection of patients, users and third parties is ensured; and d. the efficacy and performance of the medical device are not placed at risk. 4. If requested, additional information must be provided to users in one of the official languages of Switzerland.

Turkey

Professional Use: Turkish

Citation: MEDICAL DEVICE REGULATION

Article 6: (4) The information, user manuals, labels, maintenance-repair booklet and other explanations that must be given together with the medical device by the manufacturer for patients, users and practitioners, as specified in section (13) of Annex I , must be in Turkish when the medical device is placed on the market.

United Kingdom

Professional Use: English

Citation: The Medical Devices Regulations 2002

(3) In the case of a relevant device which is being or has been put into service— (a) the essential requirements specified in Sections 8.7 and 13 of Annex I with regard to information on the packaging and on any label are complied with only if such information is in English (whether or not it is also in another language and whether or not the device is for professional use); and (b) the essential requirements specified in Sections 11.4 and 13 of Annex I with regard to instructions for use are complied with only if— (i) such instructions are in English or another Community language, and (ii) if the instructions are not in English, any packaging, label or promotional literature carries a clear statement in English stating the language in which the instructions are given.