With 27 national languages throughout Europe, navigating the language requirements can be challenging. Knowing whether the labels, packaging and Instructions for Use (IFU) / User Manual (UM) must be translated is confusing and over-translating can result in unnecessary expense.
What is included in the Language Requirements Tool?
To help you maintain compliance, Casus has developed a free Language Requirements Tool, which:
- Provides the MDR/IVDR language translation requirements for the European Single Market, the United Kingdom (UK), and Switzerland
- Outlines the requirements for devices intended for the lay person versus those for healthcare professionals
- Specifies if an EU member state allows the IFU/user manual to be provided only in English
- Confirms if a National Competent Authority has published if manufacturers may request a language exemption
- The regulation excerpt and link citation for reference
We strongly recommend reading the below information in full prior to using the tool.
The MDR and IVDR state that it is the manufacturer’s responsibility to translate documentation into the local language, as required.
MDR Art.10(11): “Manufacturers shall ensure that the device is accompanied by the information set out in Section 23 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.”
As noted in the above excerpt, each member state determines the language/translation requirements in its country.
Layperson versus Professional Use
The requirement to translate IFUs/user manuals into the local language may differ within a single market, depending on the intended user of the device. Some member states dictate a requirement for all ‘users’, whereas others differentiate the requirements between layperson versus professional use/use by healthcare professionals. In these cases, the following definitions/notes should be considered:
- User: Any healthcare professional or lay person who uses a device
- Layperson: An individual who does not have formal education in a relevant field of healthcare or medical discipline.
- Professional: This generally refers to healthcare professionals
The differing requirements between a layperson versus professional is generally based on the expected language knowledge of the end user. If the local authority believes that professional users are likely to have English language proficiency, they may allow the instructions for use/user manual to be provided in English instead of the national language(s).
Some member states may allow translation ‘exemptions’ to their language requirements.
When a member state offers an exemption, it generally means that the manufacturer may submit a request to provide the IFU in a language not specified in the regulation, such as English. The manufacturer must have a strong justification that their end-users will fully understand the language in which they would like to provide the document.
Exemption allowances are typically related to professional-use products. It is not common practice for manufacturers to request exemptions and the process to request an exemption may not be clearly detailed in the member state’s regulation.
If an exemption is of interest, you may contact the national competent authority to confirm if exemptions are possible and what information is required, if so.
We have noted within the Language Requirements Tool where exemptions may be possible.
The regulation excerpts provided below are for reference only. In cases where an English translation of the regulation is not available, a Google translated version has been included instead. Casus Consulting LLC does not take responsibility for the accuracy of these translations. For full and complete information, manufacturers should review the full regulatory text linked within the tool.
Casus Consulting LLC has taken due care in preparing this Language Requirements Tool. However, we do not guarantee, nor do assume legal liability or responsibility for, the accuracy or completeness of the information contained in these materials. The language requirements are publicly available on each Competent Authority website. Links are provided in the tool and individuals should verify the information published directly by the Competent Authority prior to taking action.