Introduction

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.

Why Is IVDR Important

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.

Documents Requiring Translation

Per the IVDR, some of the documentation requiring translation is classified as mandatory, and others when a specific request is provided for additional information:

• Mandatory:  Labeling instructions, and instructions for use (IFU).  The entire IFU, along with updated content, safety and performance characteristics, and other technical documentation, must be translated into all EU languages where the product is sold.
• Mandatory:  EU Declaration of Conformity.  The declaration must be translated into official EU languages required by the countries where the device is available.
• Mandatory:  Field Corrective Actions.  When a medical device manufacturer implements field corrective actions by sending an advisory notice to inform operators and users about risks of medical devices, this documentation must be translated into official EU languages required by the countries where the device is available.

• Upon Request:  Information demonstrating the safety and conformity of the medical device.
• Upon Request: Additional technical documentation, audit reports, assessment and inspection reports.

Country-Specific Requirements

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.

Accuracy, Clarity And Accessibility

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.

Translation Best Practices

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:

• A focus on medical accuracy:  only utilize scientific experts, as they will be performing translations of highly technical content.
• A team of subject matter experts: Make sure that your translators are well-versed with your specific subject matter.
• A strategy of risk mitigation:  always combine the best-in-class quality processes, with the expertise of industry-expert quality assurance personnel overseeing every translation.

Conclusion

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.