- Which languages are allowed for instructions for use of medical devices according to the Medical Device Regulation (MDR)?
- What does this mean for you in terms of implementation?
- Which languages are permitted for instructions for use in which countries?
- What all counts as instructions for use in the first place?
- What do you have to consider when translating the instructions for use?
Let’s start directly with the “most important” question.
Which languages are allowed for instructions for use according to MDR?
With regard to the permitted languages for IFUs (Instructions for Use), the MDR does not prescribe any specific languages.
However, in Annex I (General Safety and Performance Requirements) under Section 23, the MDR requires that information on the use of a medical device, including instructions for use, be available in an official language or languages of the Member State in which the device is placed on the market or put into service. This means that the instructions for use must be available in the official language or languages of the respective EU country in which the medical device is sold. Exact regulations are provided by the respective countries. Thus, you may have to supply in multiple languages or you may have a choice.
It is your responsibility as a manufacturer or distributor to ensure that the instructions for use are available in the appropriate languages to meet the requirements of the MDR.
What exactly does that mean now in terms of implementation?
To meet the requirements of the MDR, you as a manufacturer or distributor of medical devices must consider the following two points:
- identify the target countries: you should first identify the countries where your medical devices will be placed on the market or put into service.
- Identify the official languages: In each target country, the official language(s) should be identified. There are 24 official languages in the EU, and some countries have more than one official language (see table below).
A distinction is also made as to whether the instructions for use are designed for lay users or patients or for expert users. Thus, there may be two different requirements for the language of the instructions for use in one country. Example: In Austria, the specified language for lay users and patients is German. But for expert users it may be German or English.
Another example: In a country like Luxembourg, three languages are spoken: Luxembourgish is the national language, but German and French are widely used administrative and official languages in Luxembourg. For lay users, therefore, all three languages may be present in the instructions for use here. In this example, another language is added for expert users: English! In this particular case, you must have all listed languages in your IFUs, because Luxembourg requires it. In other countries you have to check here again which specific rules apply when selecting the languages.
The languages permitted in the individual EU member states for instructions for use
| EU member state | Languages for lay users | Languages for expert users |
| Austria | German | German or English |
| Belgium | French, Dutch, German | English, French, Dutch or German |
| Bulgaria | Bulgarian | Bulgarian |
| Croatia | Croatian | Croatian, English |
| Cyprus | Greek | Greek, English |
| Czech Republic | Czech | Czech |
| Denmark | Danish | Danish |
| Estonia | Estonian | Estonian, English |
| Finland | Finnish, Swedish | Finnish, Swedish, English |
| France | French | French |
| Germany | German | German, English |
| Greece | Greek | Greek |
| Hungary | Hungarian | Hungarian |
| Ireland | English; English and Irish | English; English and Irish |
| Italy | Italian | Italian |
| Latvia | Latvian | Latvian |
| Lithuania | Lithuanian | Lithuanian |
| Luxembourg | French, German, Luxembourgish | French, German, Luxembourgish, English |
| Malta | Maltese, English | Maltese, English |
| Netherland | Dutch | Dutch, English |
| Poland | Polish, English | Polish, English |
| Portugal | Portugese | Portugese |
| Romania | Romanian | Romanian, English |
| Slovakia | Slovak | Slovak |
| Slovenia | Slovenian | Slovenian |
| Spain | Spanish | Spanish |
| Sweden | Swedish | Swedish |
(Source: Mastermindtranslations.co.uk)
What exactly counts as instructions for use?
Article 2.14 of the MDR defines instructions for use as follows: “Instructions for use means information provided by the manufacturer informing the user of the intended purpose and correct use of a device and of any precautions to be taken;”
This includes:
- Instructions for use/ user manuals
- manuals/user’s guides
- Labels and information on packaging materials
What is there to consider when translating the instructions for use?
Instructions for use should be translated into the appropriate official languages by qualified translators to ensure that the information is correct and understandable. The following must be observed:
- Compliance with national regulations: In addition to the MDR, national regulations may also apply in individual member states, which may impose further requirements on the design and content of instructions for use. You should familiarize yourself with country-specific regulations and ensure that your instructions for use comply with them.
- Your first starting point here is the national medical device authorities: Visit the website of the national medical device authority in the country for which you need information. There you will often find guidelines and regulations for the approval and labeling of medical devices, including the required languages for the instructions for use.
- Updating the Instructions for Use: You should periodically review and update the Instructions for Use (whenever there are changes to your product or regulatory changes that affect your product) to ensure that they reflect the latest requirements and information about the medical device. It should be noted that translations must also be kept up to date.
Test your user manuals for comprehensibility with real users!
Annex I, Chapter III, Section 23.1a) of the MDR states: „ The medium, format, content, legibility, and location of the label and instructions for use shall be appropriate to the particular device, its intended purpose and the technical knowledge, experience, education or training of the intended user(s). In particular, instructions for use shall be written in terms readily understood by the intended user and, where appropriate, supplemented with drawings and diagrams.” (Source: MDR)
Our recommendation at this point would be to see the IFUs as part of the product and to test them iteratively during your usability engineering according to IEC 62366-1 process. Also, for the reason that an outstanding user manual has a positive effect on the perceived product quality.
Conclusion
The MDR does not provide clear guidance on which languages are allowed and which are not. However, you must publish the instructions for use in the national language or languages for each country in which you want to sell your medical device. Here, each EU member state has its own requirements.
Do you need help creating or testing your IFUs? What is your specific case? Comment on this post or get in touch via our contact form. We look forward to hearing from you.
