On 26th May 2022, the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 will become applicable across all 27 EU Member States, marking the start of a five-year progressive roll-out for in vitro diagnostic medical devices on the EU market. Among its various changes to the EU regulatory framework are the IVDR language requirements. In this article, we will discuss what these IVDR language requirements are, and which languages individual EU Member States accept in response to them.
What are the EU IVDR language requirements?
The In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746 is the new regulatory basis for placing on the market, making available, and putting into service in vitro diagnostic medical devices (in short, IVD medical devices), across the EU. Examples of such IVD devices include blood glucose monitors, immunoassays, and coronavirus tests. As an EU regulation, on 26th May 2022 it will become immediately effective in all 27 EU Member States as well as the EFTA States, without having to be transferred into national law. Nevertheless, the laws of respective states may be adapted or official guidance provided to supplement some requirements, such as the IVDR language requirements, in more detail.
Multilingualism is one of the EU’s founding principles, enshrined in the EU’s Charter of Fundamental Rights. However, the vast linguistic diversity of the EU presents a challenge when establishing which language(s) should be used for the local version of the product literature accompanying an IVD device in a given national market. Similarly to the Medical Device Regulation (MDR) (EU) 2017/745, the IVDR gives discretion to the individual Member States to determine which official EU language(s) they will accept.
Although these language measures are already present in the current Directive 98/79/EC that is being replaced by the IVDR, the IVDR provides much more clarity on this matter. For an overview of the rationale behind the introduction of these more stringent language requirements, please see our article What Are the Language Requirements for Medical Devices Sold in the EU Market under the New EU Medical Devices Regulation?
What provisions does the IVDR make for language requirements?
The IVDR language requirements for IVD devices apply to a range of information and documentation that can be broadly categorised by intended purpose. In this article, we will focus on the information intended specifically for the end user. This information is often referred to as user- or patient-facing information, and is also known as non-technical documentation.
The provisions for language requirements set out in the IVDR mirror those found in the MDR. In that sense, the IVDR language requirements also take the form of ‘shall’ instead of ‘may’, making them mandatory. By contrast, the provisions of the current Directive 98/79/EC on in vitro diagnostic medical devices are optional.
More specifically, language requirements for user-facing information are set out in two sections of the IVDR:
Article 10(10). General obligations of manufacturers
Manufacturers shall ensure that the device is accompanied by the information set out in Section 20 of Annex I in an official Union language(s) determined by the Member State in which the device is made available to the user or patient. The particulars on the label shall be indelible, easily legible and clearly comprehensible to the intended user or patient.
The information supplied in accordance with Section 20 of Annex I with devices for self-testing or near-patient testing shall be easily understandable and provided in the official Union language(s) determined by the Member State in which the device is made available to the user or patient.
To satisfy this requirement, manufacturers must ensure that the information provided with the IVD device is translated into an official EU language(s) specified by the Member State in which it is to be sold. Section 20 of Annex I further defines this as the information needed to identify the device and its manufacturer, and any safety and performance information that appears:
• on the device itself
• on the packaging
• in the instructions for use (IFU)
Any safety and performance information relevant to the user should also be available in an official EU language(s) on the manufacturer’s website, if the manufacturer has one, and kept up to date.
In addition, this provision emphasises the importance of comprehensibility for any information supplied with devices for self-testing or near-patient (point-of-care) testing. Their very nature means that these IVD devices are intended to be used by laypersons, often in an unsupervised environment, such as the home, or by healthcare practitioners who are not medical laboratory professionals. As such, the language level of any information supplied with such devices must correspond to that reasonably expected from the intended user, so that all the information is fully understood. This is to ensure that the risk of errors in use and/or in the interpretation of results is kept to minimum.
For more practical advice on the translation of information related to medical devices, see our articles How to Prepare Your Document for a Medical Device Translation Project and How to Optimise Technical Document Translation for Your New Export Markets.
Article 84(8). Analysis of serious incidents and field safety corrective actions
The manufacturer shall ensure that information about the field safety corrective action taken is brought without delay to the attention of users of the device in question by means of a field safety notice. The field safety notice shall be edited in an official Union language or languages determined by the Member State in which the field safety corrective action is taken. […] Unless duly justified by the situation of the individual Member State, the content of the field safety notice shall be consistent in all Member States.
In keeping with its main objective of ensuring safety, the IVDR also extends its language requirements for IVD devices to field safety notices (FSNs). The device manufacturer (or their representative) must provide users with critical communications about the device malfunction in an official EU language(s) determined by the Member State where the field safety corrective action is taken.
In addition to the language requirements for the user-facing information discussed above, the IVDR also specifies language requirements for non-user-facing information, i.e. technical documentation. This information is intended for a competent authority, notified body, or other regulatory entity. These requirements are set out in Article 10(13), Article 11(3)(d), Article 17(1), Article 37, Article 48(12), Article 51(1), and Article 69(5).
What are the official languages of the EU?
The EU has 24 official languages. These are (with their corresponding EU language codes): Bulgarian (BG), Croatian (HR), Czech (CS), Danish (DA), Dutch (NL), English (EN), Estonian (ET), Finnish (FI), French (FR), German (DE), Greek (EL), Hungarian (HU), Irish (GA), Italian (IT), Latvian (LV), Lithuanian (LT), Maltese (MT), Polish (PL), Portuguese (PT), Romanian (RO), Slovak (SK), Slovenian (SL), Spanish (ES), and Swedish (SV). All 24 languages enjoy equal status and, for the purpose of the IVDR language requirements, are considered as official languages.
For a more detailed discussion on the official languages of the EU and their use, please see our article Which Languages Are Accepted under the MDR Language Requirements in Each EU Member State?
Which languages do individual EU Member States accept in response to the IVDR language requirements?
The table below shows the official EU languages each EU Member State accepts for IVD devices placed on their respective markets under the IVDR.
| EU Member State | For Patient | For Professional User |
|---|---|---|
| Austria | German | German; English acceptable* |
| Belgium | French and Dutch and German | English acceptable; French or Dutch or German upon user’s request* |
| Bulgaria | Bulgarian | Bulgarian |
| Croatia | Croatian | Croatian and/or English |
| Cyprus | Greek | Greek or English |
| Czech Republic | Czech, exceptions allowed* | Czech, exceptions allowed* |
| Denmark | Danish | Danish, exceptions allowed* |
| Estonia | Estonian | Estonian, exceptions allowed* |
| Finland | Finnish and Swedish | Finnish and/or Swedish or English, conditions apply* |
| France | French | French |
| Germany | German | German or English or another language, conditions apply* |
| Greece | Greek | Greek, exceptions allowed* |
| Hungary | Hungarian | Hungarian |
| Ireland | English or English and Irish | English or English and Irish |
| Italy | Italian | Italian |
| Latvia | Latvian | Latvian |
| Lithuania | Lithuanian | Lithuanian |
| Luxembourg | French or German or Luxembourgish | French or German or Luxembourgish or English |
| Malta | Maltese or English | Maltese or English |
| Netherlands | Dutch | Dutch or English, conditions apply* |
| Poland | Polish | Polish or English, conditions apply* |
| Portugal | Portuguese | Portuguese |
| Romania | Romanian | Romanian |
| Slovakia | Slovak | Slovak |
| Slovenia | Slovenian | Slovenian, exceptions allowed* |
| Spain | Spanish | Spanish |
| Sweden | Swedish | Swedish, exceptions allowed* |
Disclaimer: Please note that the information provided in this Table is for reference only, and based on both official and unofficial translations. Therefore, the original legally binding language version should always be used. In case of any doubt, the competent authority from the relevant EU Member State must be consulted. All details correct at the time of publication.
Where can we find more detailed information?
If you would like more detailed information on the languages accepted in individual EU Member States under the IVDR language requirements, please see the link below.