Medical Device Translations: Using Translation Memory for MDR and IVDR Compliance

Achieving accurate and consistent translations has always been essential in the global medical device industry. However, it is now even more crucial in light of the Medical Devices Regulation (EU) 2017/745 (MDR) and In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR). To ensure translation consistency while meeting the requirements of MDR and IVDR, translation memory (TM) technology has become indispensable to the translation process.

In this article, we explore the importance of consistency and how leveraging TM can help achieve this goal when handling medical device translations.

Why is consistency important for medical device translations?

Consistency in medical device translations is vital for regulatory compliance, patient safety, and international market credibility. This is because accurate and consistent translations minimise the risk of miscommunication, enabling medical device companies to thrive in global markets while protecting their reputation.

What is translation memory technology?

Translation memory technology is a powerful tool for maintaining consistency in medical device translations. By storing previous source texts and their approved target translations, the technology then identifies similar text in new documents. Here are several ways this can contribute to achieving the goal of consistency:

1. Reusing approved translations

TM allows us to reuse previously translated content by identifying approved translations that are either identical or similar to your new content. This ensures that the same terminology and phrasing are used consistently across all your documents and projects, keeping them in line with MDR and IVDR requirements.

2. Terminology management

TM tools also facilitate the creation and management of terminology databases, ensuring consistent usage of standardised terms specific to medical devices. This consistency results in clear communication, which is vital for accurate understanding and regulatory compliance.

3. Efficient update management

During the approval process, there may be necessary changes to your translations. TM streamlines this process by identifying all segments containing the text that requires modifications. This ensures that any necessary changes are implemented consistently across all of your translated materials.

4. Collaboration and quality assurance

TM technology encourages collaboration among translation teams and stakeholders, enhancing both consistency and overall quality. By accessing the same TM database, multiple linguists can work simultaneously to speed up the process while keeping your translations consistent. These tools also include several quality assurance checks, helping identify and resolve linguistic errors or inconsistencies.

5. Customisation for MDR and IVDR compliance

To comply with MDR and IVDR, translation service providers like Intertranslations can customise TM databases specifically for medical device translations. This customisation incorporates approved regulatory terminology, as well as any industry standards, guidelines, and unique requirements of MDR and IVDR. Such tailored TM solutions further enhance consistency and regulatory compliance in medical device translations.

Helping you produce quality medical device translations

In the competitive medical device industry, achieving consistency in translations is essential for MDR and IVDR compliance and international success. Translation memory technology offers a practical solution by reusing approved translations, managing terminology, facilitating updates, promoting collaboration, and ensuring overall quality.

By leveraging TM effectively, we support medical device companies by delivering accurate and consistent translations. This reinforces your commitment to patient safety and enhances market competitiveness, while also ensuring that your documents comply with local regulations. Contact us to learn more about how our TM expertise can benefit your medical device translation needs.