The IVDR requires that all information accompanying medical devices, including marketing materials, must be translated into the official EU languages of the markets where the device is sold.
EU Regulation 2017/746 is a regulation enacted in 2017 for releasing in-vitro medical devices into the European Union. It was published in April ’17 and is closely aligned to the EU regulation on medical devices.
The IVDR has a significant impact on Medical Devices companies from a language translation perspective, as they initiate clinical trials in one of the EU countries, or when they release a product with its corresponding marketing material into the market. With all such materials, IVDR mandates that any information accompanying medical devices must be provided in the EU languages accepted in the markets where the device is sold.
IVDR’s primary goal is an enhanced level of patient safety, from what existed within the previous EU Medical Devices Directive (MDD). Here’s an excerpt of the IVDR, “This Regulation aims to ensure the smooth functioning of the internal market as regards to in-vitro diagnostic medical devices, taking as a base a high level of protection of health for patients and users, and taking into account the small and medium-sized enterprises that are active in this sector. At the same time, this Regulation sets high standards of quality and safety for in-vitro diagnostic medical devices in order to meet common safety concerns.”
According to Medenvoy, the MDD previously required manufacturers to confirm the translation of their labeling into the languages of each European country where the device is sold. Manufacturers had an EU Authorized Representative (EC REP) that reviewed labeling for compliance, however, EC REPs did not always have clear insight into where products were being distributed in the EU after they reached a distributor.
With IVDR taking effect, compliance checks for both distributors and the importing organization are now a necessity by law.
Per the IVDR, some of the documentation requiring translation is classified as mandatory, and others when a specific request is provided for additional information:
IVDR places the responsibility on each EU nation to determine which languages are required. For easy reference, in January 2024, the European Commission Directorate-General for Health and Food Safety published a table of all European Union country and their IVDR language requirements, by type of content.
With IVDR, any medical device marketed in an EU country must be accompanied by clear labeling and instructions in the local language. IVDR also contains language saying that the translated content must be accurate and easy to understand, including for non-medical professionals. What is most important to understand is that IVDR covers much more than just ensuring that content exists in the required languages where the device is marketed. IVDR rules set clear standards for the accuracy, clarity, and accessibility of that content, and meeting these standards is not a one-time effort, but an on-going process.
The two tried-and-verified steps when translating any medical documents, but especially those that need to comply with IVDR, is to utilize professional translators, combined with a quality assurance process that also maintains a high degree of consistency.
Follow these three key value drivers, for each of your translating projects:
With the advent of IVDR, accurate translations has taken on a greater urgency. There is a direct impact on market access, if the languages required by each EU are not included in the translated material. Non-compliance to the regulation also comes with significant consequences, including delays in clinical trial execution or product release approval, by the relevant health authorities.
By prioritizing high-quality translations that are compliant with IVDR, device manufacturers are not only ensuring patient safety, but successful and timely market entry for their products.
Check out this short video to learn more about Language Scientific and our translating expertise, ensuring that you are being IVDR compliant.
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