EU Language Requirements for Medical Devices: A Guide to MDR & IVDR Compliance
EU Language Rules for MDR & IVDR Medical Devices
Medical devices and in vitro diagnostic devices are safe and efficient for their users in all Member States. One important issue of compliance related to MDR 2017/745 and IVDR 2017/746 regulations is the language in which the information about the products is delivered. It is crucial that all the documentation is in line with the official language of the country in which the device is marketed or used.
What About Translations?
The translations must be accurate and valid. Many companies use professional, medical translators to minimize misinterpretations. Misinterpretations can result in non conformity, confusion on the user’s part, and in the worst case, product recalls.
Why This Matters (Risks Of Non compliance)
Failure to adhere to language requirements could result in a device being classified as a non conformity under MDR/IVDR, causing the potential for recalls, market withdrawals, or limitations.
Incorrect or unintelligible translation could increase the risk of improper use and adverse reactions, thereby increasing the risks involved.
Inability to comply with language requirements could also cause problems related to post market monitoring, since users/patients would be unable to follow instructions or report adverse incidents.
Who Is Responsible For Ensuring Language Compliance?
Under MDR and IVDR:
The primary duty of ensuring compliance with language requirements lies with the manufacturer.
The Importer/Distributor has to make sure that the product that it markets complies with the language requirements, including the availability of documentation in the proper language.
Authorized Representatives (ARs) have to make sure that the manufacturer meets these obligations, especially when it comes to non EU manufacturers.
Legal References And Obligations In MDR And IVDR Under MDR
The label and packaging of the device shall include the necessary particulars and Instructions for Use (IFUs) shall be provided. (See MDR Annex I, Chapter III - Section 23)
The information shall be “readily understandable by the intended user” (which suggests language usability) and in a format suitable for the intended user, including language, training, and technical knowledge.
Regulation (EU) 2017/745 on Medical Devices (MDR) provides several legal provisions allowing Member States to determine language requirements for manufacturers in order to provide information in relation to the device at national level. The following table provides an overview of the national provisions in case Member States have used the opportunity to determine language requirements for manufacturers.
Member States are not obligated to define specific language. Taking into account the costs associated with providing information in different languages, Member States are recommended to think about the possibility of using other languages than their national one (e.g. English language) in case the safety use of the device will not be violated, particularly devices for professional use.
Member States have the right to define the official languages of the Union that apply to the territory of a particular Member State. The manufacturers must comply with that national requirement. (See the Table "MDR - Language requirements for manufacturers" on the website of the European Commission).
Other language requirements: For Summary of Safety and Clinical Performance of a device (SSCP), Art. 32 MDR, see MDCG-2019-9 Rev.1 guidance document which recommends that SSCP "should be written in a way that is clear to the intended user and, if relevant, to the patient (see MDR, Annex II (2), Article 10 (11)), the SSCP should be translated into the languages accepted in the Member States where the device is envisaged to be sold" (p. 6)
Under IVDR
The information listed in section 20 of annex I relates to labelling, instructions for use, any symbols, user interface etc., and shall comply with language requirements.
In accordance with MDR, the Member State may establish which official language(s) shall apply; where the information is given in another language (for instance English), but only if the Member State permits and the safe use is not affected. See table provided by the Commission for IVDR, for the diversity of language requirements by Member State.
The Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR) contains different legislative acts that permit the Member States to establish language requirements for manufacturers at national level for information accompanying the device. The table below provides a general overview of the national provisions, in case that Member States have made use of the option to determine language requirements for manufacturers. (See table of European Commission “IVDR – Language requirements for manufacturers”)
The Member State is not obliged to determine the language. Considering the costs associated with information being given in several languages, Member States are advised to assess whether the information to be provided by the manufacturer could be provided in another language than the national one (such as in English), without affecting the safe use of the device, especially professional devices.
Practical Implications And Country specific Variations
While the regulation gives the general obligation, the languages in question would depend on the Member State where the device is made available. Tables provided by the European Commission state the countries that need their official national language, and whether they can allow the English language (for professional use devices).
Some Member States may accept English language for professional use devices if no harm occurs; some insist on using their national official language(s) for all devices including those for professionals.
Manufacturers who are selling their product into many EU markets (your case is in markets like Austria, Germany, Netherlands, Belgium, France, Greece, Italy and so on) must find out which language is required for every country, and then make sure the correct language versions of labels and IFUs are used.
In case the device is made for lay persons (patients), then you are generally required to have the documents in the national language of the country of the user and not in English.
One of the major gray areas is the e IFU (electronic Instructions For Use) and whether “on device”, “on packaging” or “online” documentation can replace the printed IFU; but the obligation of language remains the same: users should get the information in their required language.
Key Compliance Steps For Manufacturers/Distributors
Early in your market access planning, create a table of all Member States where you intend to place the device and list the official language(s) required for label/IFU/documentation for each. Use the Commission's tables (for MDR & IVDR) as reference.
Ensure that your label and IFU content development process includes translation into each required language and that it is reviewed/validated (ideally by a person familiar with the medical/technical context and the target language).
Determine whether your device is for professional users or lay/patient users; many Member States allow more flexibility (e.g., English) for professional devices, but not always for patient use devices.
Update your QMS and change control process: If you change your IFU content, label, packaging, you must trigger translation updates and verify for each language version.
Ensure that instructions, user interfaces, packaging etc. consider the language abilities of the intended user: the text must be clearly understandable to the user in that language. (MDR Annex I, Chapter III)
Keep records of which language versions you have provided to which markets, and evidence of translation/validation, as this may be requested by Notified Bodies or Competent Authorities during audits.
Conclusion
Language conformity in relation to MDR and IVDR is a very important part of gaining access to the market in the European Union. Failure to take this into account may result in delays in regulation, penalties, or even product withdrawal from the market. With a proper attitude and the knowledge of what is required of you, the process will go smoothly.
How Morulaa Can Help
Morulaa enables medical device companies to satisfy language regulations of the EU by creating an understanding of country specific legislation, coordinating translations performed by authorized translators, validating the information within IFU and labeling, as well as acting as your EU Authorized Representative.
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