Manufacturers must translate their medical device and IVD labeling into the official language(s) required by the EU member state. This is mandatory so that end users will understand how to correctly use the product.
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.
To help you maintain compliance, Casus has developed a free Language Requirements Tool. Its benefits include:
Provides the local requirements for the European Single Market,
the United Kingdom (UK), and Switzerland
Outlines the requirements for devices intended for the lay person and for healthcare professionals
Specifies if a member state allows the IFU/user manual to be provided in English
Confirms if a national competent authority has published that manufacturers may request a language exemption
The regulation excerpt and link are included for reference
We strongly recommend reading the below information in full prior to using the tool.
The regulation excerpts provided below are for reference only. In cases where an English translation of the regulation is not available, we have included the Google translated version instead. Casus Consulting does not take responsibly for the accuracy of these translations. For full and complete information, manufacturers should review the full regulatory text linked below.
Casus Consulting has taken due care in preparing this language tool, but we do not guarantee, nor do we 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 as published by the Competent Authority prior to taking any action.
state that it is the manufacturer’s responsibility to translate documentation into the local language, as required. For reference, 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.
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