Medical device “labelling” language requirements under the EU MDR and IVDR

First of all, language requirements in Regulations (EU) No. 2017/745 on medical devices (EU MDR) and 2017/746 on in-vitro diagnostic devices (IVDR) are not limited to “labelling”. They also apply to various other regulated documents like EU Declarations of Conformity, official statements, the technical documentation that is subject to conformity assessment by Notified Bodies, or Field Safety Notices.
The EU Commission has published compilations of the applicable requirements under the EU MDR and IVDR, but some aspects remain convoluted.
This blog article focuses on languages for “labelling” only, which already illustrates the complexity of addressing the requirements in a territory where more than 20 languages need to be considered.

Replaces version of 17.06.2020

Key takeaways:

  • “Labelling” is being interpreted broadly. Language requirements not only affect direct labelling of devices, packaging labels, and instructions for use, but also implant cards, SSCP/SSP, software graphic user interface (GUI) and marketing materials.
  • Labelling language requirements are left to the discretion of the EU Member States, Iceland, Liechtenstein, Norway, and Turkey.
  • Manufacturers need to become familiar with and adapt to labelling language requirements in each country where they wish to market their devices. Without the required labelling translations, a device is unduly placed on the market.

Content:

Which information is affected by EU MDR/IVDR labelling language requirements? And what is labelling, in fact?

The term “labelling” should be avoided for regulatory purposes, as it is confusing.

“Labelling” is used multiple times throughout the EU MDR and IVDR and mostly refers to packaging labels. However, there is no legal definition of “labelling”. The guidance documents issued by the Medical Device Coordination Group (MDCG) refer to “labelling” sometimes as synonym of labels only, and sometimes as synonym of labels and instructions for use (IFU). 

The new version of ISO 18113-1 relative to IVD labelling refers to the definition of “labelling” in EN ISO 13485:2016, which is equivalent to information supplied by the manufacturer and includes: labels and IFU, plus any information on device identification, intended purpose, technical description or proper use. This concept matches the recommendation of the International Medical Device Regulatory Forum (IMDRF) in its principles of labelling, IMDRF GRRP-WG/N52.

Indeed, “information supplied” with the device by the manufacturer is a better term than “labelling”. It corresponds to what is required per Chapter III of the General Safety and Performance Requirements (GSPRs), i.e. Annex I of the EU MDR and IVDR. It covers the information necessary to identify the device and its manufacturer as well as any safety and performance information to be provided by the manufacturer on the:

  • device itself (i.e. direct labelling, including on-software labelling), 
  • packaging labels
  • Instructions for Use (IFU), regardless of the medium (i.e. paper or electronic form), and on the
  • manufacturer’s website.

Additional documents concerned as “information supplied” by the manufacturer are:

Implant Cards

Per EU MDR Article 18, manufacturers of implantable devices must supply an implant card together with the implanted device, with certain exceptions (i.e. sutures, staples, dental fillings, dental braces, tooth crowns, screws, wedges, plates, wires, pins, clips, and connectors). In addition, the manufacturer must provide instructions in the IFU for the healthcare professional who must fill out the implant card.

EU MDR Article 18(1) indicates that the information provided in the implant card shall be stated in the language(s) determined by the concerned Member State. Guidance document MDCG 2019-8 recommends the use of recognized symbols to avoid national versions, i.e. translations. Yet, there is no symbol for “device type” and this information on the implant card needs to be provided in the required national languages. A non-exhaustive list of terminology for “device type” in English is available from guidance document MDCG 2021-11. The manufacturer is responsible for their correct translation.

Summary of Safety & Clinical Performance (SSCP) / Summary of Safety & Performance (SSP)

The Summary of Safety and Clinical Performance (SSCP) required per EU MDR Article 32 for all implantable and Class III devices, and the Summary of Safety and Performance (SSP) required per IVDR Article 29 for all Class C and D IVDs, are also viewed as “labelling”. They convey essential information about the device to the end user or the patient. Thus, SSCP and SSP must be written in a way that is understandable for the intended reader.

For the SSCP, translations are justified in guidance document MDCG 2019-9, by analogy to the IFU requirements. As such, the SSCP content intended for patients should be provided in all the languages required for IFUs intended for laypersons in the Member States concerned. If the required languages do not include English, an English translation must also be provided because it is the most common language in scientific publications and widely understood by healthcare professionals. MDCG 2019-9 further requires that one SSCP document be created per language, and that the language validated by the Notified Body be indicated. By analogy, the same requirement might be applied to the SSP.

What about the language of the graphic user interface (GUI) in medical device software?

Many EEA countries do not have specific requirements on graphic user interface (GUI) languages because the GUI can be considered a component of the device, and not labelling. 

With standalone software (incl. mobile apps), it can be difficult to distinctly separate instructions for use from the actual software functions, since the information supplied by the manufacturer is provided on the device itself, i.e. the software’s GUI. As a result, it might be easier to consider the entire GUI as labelling, and have it entirely translated for the countries that require labelling in local language.

When the GUI is viewed as a component, manufacturers must ensure that it complies with the relevant General Safety & Performance Requirements (GSPRs) in Annex I of the EU MDR or IVDR, in particular those relative to risks related to use errors. This requirement can be fulfilled by different means: symbol-based GUI, fully or partially translated GUI, or clearly explaining the English GUI in the IFU available in the local language, for safe and correct use. The manufacturer should justify the chosen solution and document it in the Risk Management File.

Some countries have very explicit positions on GUI language.

  • Denmark: The Danish Medicines Agency’s website recognizes that there are no general requirements and that, beyond IFUs, it is the responsibility of the manufacturer to determine which information is necessary for the proper and safe use of the device, implicitly requiring that type of information to be considered “labelling”, thus subject to translation. They also indicate that buttons, keys or displays with single words or terms like “Load”, “Enter” and “Page down” are viewed as symbols and are exempted from translation on the software but should be explained in the IFU.
  • Hungary: The National Institute of Pharmacy and Nutrition OGYÉI’s website also provides information on software translations. In general, the GUI must be available in Hungarian (except standardized pictograms), regardless of whether the device is for professional or other layman use. As to displays, they could be in English if extremely simple and provided the Hungarian IFU explains the screenshots. OVYÉI reminds manufacturers that, even for professional use, it “cannot be expected from service providers to have a certified and employer-accepted language proficiency in any language other than Hungarian”.
  • Norway: The Norwegian Medicines Agency’s website contains detailed guidelines on “labelling”, and explicitly requires software to be in Norwegian.
  • Poland has detailed GUI language requirements by law. The GUI of software for layman use must be in Polish. However, English GUI is acceptable under the following conditions:
    • the device is not intended for use in situations of immediate health and life threat,
    • all concepts, symbols, and commands are explained in the Polish IFU, 
    • the English GUI does not pose a risk to the user, and is clearly marked on the commercial packaging.
      As to software for professional use, it may have English GUI, except for the patient-facing part of the GUI, to which the conditions in the previous sentence apply.
  • Romania has implemented GUI language requirements by law. GUI for non-specialists must be provided in Romanian. English GUI is acceptable, if justified, for professional use only and upon written consent by the user.

What about marketing materials?

Marketing or promotional materials are not mentioned in the EU MDR or IVDR as part of the information to be supplied by the manufacturer. In principle, language requirements in the national legislation adopting the EU MDR and IVDR do not apply to them. 

More explicitly, standard EN ISO 20417 on the information to be supplied by the manufacturer of medical devices excludes promotional materials (called marketing information) from its scope, but indicates that some jurisdictions may consider such supplemental information as information supplied by the manufacturer, which is the case for example in the US. This exclusion from scope is carried over word by word from IMDRF’s Principles of Labelling for Medical Devices and IVD Medical Devices, IMDRF GRRP-WG/N52

Marketing materials (including those provided on the manufacturer’s website) are not explicitly considered “information supplied by the manufacturer” in the national legislation of EEA countries and Turkey implementing the EU MDR and IVDR. However, national jurisdiction on medical device advertising and promotion may contain additional language requirements.

Which languages should the manufacturer consider for “labelling” translations?

EU MDR Article 10(11) and IVDR Article 10(10) explicitly require the manufacturer to supply the information required in Chapter III of Annex I in the “official Union language(s) determined by the Member State in which the device is made available to the intended user or patient”. 

In other words, the EU MDR and IVDR do not provide any information about which languages are required for which “labelling” elements and what exceptions, if any, apply. 

Because the EU MDR and IVDR apply in the European Economic Area (EEA) and Turkey, manufacturers would need to seek the information in the national legislation of each country within the territory where they intend to sell the devices. To help in this endeavor, the EU Commission has published in a bespoke webpage the below compilations of language requirements, which is already a helpful basis but is unfortunately not up-to-date for some countries or aspects:

The EEA encompasses the current 27 European Union (EU) Member States plus 3 of the 4 members of the European Free Trade Association (EFTA), i.e. Iceland, Liechtenstein, and Norway. Switzerland is a particular member of the EFTA, which is not part of the EEA. See also chapter What about Switzerland?”.

The table below shows the official national languages in the EEA and Turkey.

Country

EU relation­ship

Official lan­guage(s)

Austria

EU Member State

German

Belgium

EU Member State

Dutch, French, and German

Bulgaria

EU Member State

Bulgarian

Croatia

EU Member State

Croatian

Cyprus

EU Member State

Greek and Turkish

Czech Republic

EU Member State

Czech

Denmark

EU Member State

Danish

Estonia

EU Member State

Estonian

Finland

EU Member State

Finnish and Swedish

France

EU Member State

French

Germany

EU Member State

German

Greece

EU Member State

Greek

Hungary

EU Member State

Hungarian

Iceland

EFTA member

Icelandic

Ireland

EU Member State

Irish and English

Italy

EU Member State

Italian

Latvia

EU Member State

Latvian

Liechten­stein

EFTA member

German

Lithuania

EU Member State

Lithuanian

Luxem­bourg

EU Member State

French, German, and Luxem­bourgish

Malta

EU Member State

Maltese and English

Norway

EFTA member

Norwegian

Nether­lands

EU Member State

Dutch

Poland

EU Member State

Polish

Portugal

EU Member State

Portuguese

Romania

EU Member State

Romanian

Slovakia

EU Member State

Slovak

Slovenia

EU Member State

Slovenian

Spain

EU Member State

Spanish

Sweden

EU Member State

Swedish

Turkey

Customs Union

Turkish

These would add up to 27 languages, in addition to English. However, not all of them are required for medical device labelling and/or exceptions are possible for professional use in some countries, resulting in a patchwork of language requirements, as described in the next section.

How do EEA countries implement “labelling” language requirements?

Labelling language requirements are implemented in the relevant national legislation of each EEA country and Turkey. Sometimes, supplementary information or positions are published on the websites of the national competent authorities.

Because the legislation enacted in these countries mostly refers to the GSPR section on the information to be supplied by the manufacturer, it implicitly covers both labels and IFUs.

Under the former Directives (MDD, AIMDD, IVDD), the approach to “labelling” language was very categorical, with most countries mandating national language only and leaving very little room for waivers or English for professional use. This has changed under the EU MDR/IVDR.

Today, by law, different situations are possible:

  1. Local language is mandatory, without exceptions.
    Countries concerned: Bulgaria, Czech, France, Hungary, Italy, Lithuania, Portugal, and Spain.
  2. Local language is required, but portions of the labeling (usually information that does not relate to safety) may be in English or other languages.
    In practice, these “exceptions” do not simplify translations much, so this group is like the previous one.
    Countries concerned: Finland and Germany.
  3. Local language is required but exceptions for professional use are possible (English or other languages), under conditions and subject to prior approval, which may be limited in time.
    Countries concerned: Denmark, Greece, Norway, Romania, Sweden, and Turkey.
  4. Local language is required but exceptions for professional use are accepted (English or other languages), in some cases under conditions, but without prior approval.
    Countries concerned: Austria, Belgium, Croatia, Cyprus, Estonia, Iceland, Latvia, Liechtenstein, Luxembourg, Netherlands, Poland, Slovakia and Slovenia.
  5. English is accepted with no limitation (i.e. for either layman or professional use).
    Countries concerned: Ireland and Malta.
    In addition, by virtue of post-BREXIT agreements between the UK and the EU, Northern Ireland is a UK territory where the EU MDR and IVDR apply, and where English only is acceptable for device labelling.

These cases are generically illustrated in the EEA map below (i.e. without Turkey, but including the non-EEA Switzerland).

Manufacturers of “legacy” devices (i.e. still CE-marked under the former Directives) should be aware that the positions described above correspond to the national legislation in adaptation to the EU MDR/IVDR, and the positions might not apply  for “legacy” devices. This is important because the previous national legislation in transposition of the former Directives used to be more restrictive regarding translations.

What about Switzerland?

Since the disruption of the Mutual Recognition Agreement (MRA) between Switzerland and the EU, Switzerland is viewed as a third country and the EU MDR/IVDR do not apply directly. However, Switzerland decided to adapt its legislation to these Regulations and follows the same principles for “labelling”.

Article 16 §2 of the Swiss Medical Device Ordinance (SR 812.213, MedDO) and Article 15 §2 of the Swiss In-vitro Diagnostic Ordinance (SR 812.219, IvDO) require medical device labelling (understood to be labels and IFUs, per MedDO Art. 16 §1 and IvDO Art. 15 §1) to be available in all three official languages of Switzerland, which are German, French, and Italian. Symbols established by means of technical standards may be used to replace plain text.

Now, MedDO Article 16 §3 and IvDO Article 15 §3 allow labelling to be provided in fewer than the three Swiss official languages or in English only, under all of the following conditions

  • The device is either supplied exclusively to professionals, is a custom-made device, or a device manufactured and used exclusively within a healthcare institution.
  • The user meets the necessary requirements (i.e. professional and linguistic) and qualifications, and is in agreement.
  • The protection of patients, users and third parties is ensured, and the effectiveness and performance of the medical device are not placed at risk by not providing translated labelling.

These conditions are very similar in Liechtenstein, albeit for German only, since both countries are tied by a Customs Treaty, RS 0.631.112.514, of which Annex I (available from Liechtenstein’s law gazette no. 280) indicates that the Swiss MedDO and IvDO apply in Liechtenstein with just a few articles being excluded.

In addition, MedDO Article 16 §4 and IvDO Article 15 §4 require that, if the user requests so, additional information must be provided in one of the three Swiss official languages.

What do ”labelling” language requirements mean for manufacturers?

Medical device (incl. IVD) manufacturers cannot ignore the language requirements of each individual country in which they wish to market their devices. Without the appropriate “labelling” language, a device is unduly placed on the market. As such, the most impending need for the manufacturer is to collect and understand the current language requirements in its target EEA countries and Turkey.

Translations for device labels can be partially circumvented by using internationally recognized symbols from Harmonised Standards or Common Specifications. Harmonised standard EN ISO 15223-1:2021 is the main source of symbols under the EU MDR and IVDR. However, if none exist for the area to be covered, the symbols or identification colors must be explained in the product documentation, basically the IFU. This means they are again subject to the translations.

Ultimately, this implies that the manufacturer’s Quality Management System must include a translation procedure that describes who is qualified to undertake translations, how accuracy of translations shall be verified (e.g. through back translations), and the process for keeping translations up-to-date, when the original version changes. Moreover, when software UI is involved in a medical device or IVD, the software design and development process must incorporate the UI language requirements, in consideration of risk management and usability engineering aspects. 

This also means that the manufacturer’s internal product release processes are adapted so that the devices can only be delivered to the respective countries if accompanied by the required translated labelling or that users receive the translated labelling upon request.

Device manufacturers cannot ignore the labelling language requirements of each individual country in which they wish to market their devices.

What responsibility must importers and distributors assume?

Importers and distributors are indirectly responsible for verifying labelling language compliance since, per EU MDR/IVDR Article 13(2) for importers and EU MDR/IVDR Article 14(2) for distributors, they must verify appropriate labelling before making the device available on the market. As such, importers and distributors should verify that the devices they receive are labelled according to the national language requirements.

When an importer or distributor undertakes country-specific relabelling to a medical device, which may include translating the instructions for use and other documentation, Article 16 of the EU MDR/IVDR applies. When the importer/distributor undertakes translations or repackaging/relabelling on its own, then:

  • Per Article 16(3), it shall:
    • Indicate on the device or its packaging or in a document accompanying the device, the activity carried out (i.e. translation or repackaging/relabelling) together with its name and address.
    • Have a Quality Management System (QMS) in place with procedures that ensure that translations are accurate and up to date, that the related relabelling and/or repackaging activities do not have any impact on the original condition of the device, that the new packaging is of adequate quality, and that the importer/distributor is informed of any corrective action taken by the manufacturer in relation to the concerned device. Note that such QMS must be certified by a Notified Body, as further described in guidance document MDCG 2021-23.
  • In addition, per Article 16(4), it shall:
    • Inform the manufacturer and the concerned national competent authorities of the intention to make the relabelled/repackaged device (incl. translations) available on the market, at least 28 days prior to doing so.
    • Submit to the competent authority, within the same period of 28 days, the certificate issued by a Notified Body attesting that the QMS in place complies with the requirements in Article 16(3).
    • Be in a position to provide, upon request, mock-ups of the relabelled or repackaged device (incl. translations) to the competent authority.

Now, if these repackaging or relabelling (incl. translations) are executed on behalf and under the control of the manufacturer, EU MDR/IVDR Art. 16(2), (3) and (4) do not apply. This is clearly stated in guidance document MDCG 2021-26 (Q&A on repackaging and relabelling activities). Repackaging or relabelling undertaken on behalf and under the control of the manufacturer is merely considered a subcontracted actitiviy, and must be managed accordingly. 

For specific details on how translations impact Swiss importers, please read our bespoke blog article.

How Decomplix can help

Decomplix provides advisory services on all regulatory and quality assurance issues related to medical devices.

Our team would be happy to assist you with regulatory compliance and specific questions regarding the EU MDR or the language provisions. We are monitoring the developments in all Member States and our team of experts is always available to assist you. If you have further questions on language provisions and EU MDR do not hesitate to contact us.

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