Transitioning from MDD to MDR: How to Save on Translation Costs

The transition from the MDD (Medical Device Directive) to the MDR (Medical Device Regulation) has brought about a significant increase in the information requirements that must be provided together with medical devices.

As outlined in Annex I, Chapter III of the MDR, both labelling and instructions for use (IFU) require more information compared to the previous directive.

These increased information requirements can result in a 40% to 200% rise in IFU content, leading to higher translation costs.

To mitigate this impact, it is essential to implement strategies that optimise the translation process and ensure consistency and efficiency in multilingual content management.

Below are a series of strategies aimed at reducing the translation budget.

Reuse of Existing Content

When writing new IFUs in compliance with the MDR, it is advisable to make the most of the information blocks already present in the previous versions of the IFUs under the MDD.

This practice not only reduces the volume of content to be translated, but also ensures terminological and stylistic consistency. To achieve this, it is essential that technical writers avoid modifying previously approved texts, unless strictly necessary.

Implementation of Computer-Assisted Translation (CAT) Tools

CAT tools enable the creation of translation memories and terminology glossaries based on previous translations that have undergone quality control and that, ideally, have been reviewed by distributors or local offices. This approach facilitates:

• Reduced turnaround times.
• Cost savings by reusing already translated texts.
• Reduced risk of errors or inconsistencies by using previously approved terminology.

Content Optimisation

1. Linguistic Review: Once the IFU has been drafted, it is advisable to conduct a review with the aim of expressing the same information in fewer words. Using fewer words means less content to translate, resulting in lower costs.
2. Use of Visual Elements: Incorporating images, diagrams, or infographics can reduce the amount of text needed, making it easier to understand and decreasing the volume of content to be translated.

Use of English as the Source Language

Writing IFUs in English from the outset can be advantageous, as the language usually requires fewer words to express concepts and is widely used in the medical field. Furthermore, there are a greater number of technical and human resources available for translation from English into other languages, which can reduce costs and improve translation quality.

Post-Editing Evaluation

Analysing the feasibility of post-editing involves assessing the quality of the machine translations generated by specialised engines. If the quality is acceptable, a subsequent human review (post-editing) can be performed, which may be more cost-effective than a fully manual translation.

Formatting and Phrasing Consistency

Using systems that help maintain and reuse information blocks, including formatting, is crucial. Consistency in structure and phrasing facilitates translation and ensures uniformity across all documents.

Conclusion

The transition to the MDR presents significant challenges in terms of information management and IFU translation. However, by implementing strategies such as the reuse of content, the use of CAT tools, text optimisation, the use of English as the source language, post-editing evaluation, and formatting consistency, it is possible to minimise translation costs. These practices not only contribute to economic efficiency, but also guarantee the quality and consistency of the information provided to medical device users.

If you need help with the translation of medical device documentation, you can contact AbroadLink. We will be happy to help you!