Medical Device Localisation: Ensuring Consistency Between IFUs and UIs
Medical device IFUs and user interfaces are not always localised at the same time or by the same team. An IFU may be translated during one documentation cycle, while UI strings are handled separately during software localisation. Without terminology control across both components, different French terms can be introduced for the same function.
Each translation may be correct in isolation. The inconsistency appears only when the user moves between the instructions and the device. This impairs user experience, and can create a risk for the patient.
Terminology consistency between medical device IFUs and UIs
Consider an English device using “Confirm measurement” as a UI command.
The French UI displays: Confirmer la mesure
The corresponding French IFU instructs the user to: Valider le résultat
Confirmer and valider are both legitimate translations in many contexts. Mesure and résultat may also be appropriate depending on the device. However, if both expressions refer to exactly the same function, the user is being asked to recognise that two different terms describe one action.
The issue is therefore not whether either translation is linguistically incorrect. It is whether the terminology used in the IFU leads the user clearly to the function displayed on the interface.
This distinction becomes particularly important when the device contains several confirmation, validation or result-management functions. A terminology difference that appears minor during translation review can become ambiguous during actual use.
Inconsistent terminology can affect usability and patient safety
Terminological inconsistencies can introduce hesitation at the point of use. A user may search for a command that does not appear on screen, question whether the instruction refers to another function, select the wrong option or interrupt the procedure to verify what is required.
The consequences depend on the device and the action concerned. In some cases, the effect may be limited to additional cognitive effort or a delay. In others, ambiguity may contribute to incorrect device operation, misinterpretation of a result or failure to complete a required step.
This is relevant to the MDR risk framework. Annex I requires manufacturers to reduce risks associated with use error and to consider the knowledge, experience and characteristics of intended users. The MDR also requires instructions for use to be appropriate to those users and written in terms they can readily understand.
Terminological consistency between the UI and IFU is not explicitly presented in the MDR as a standalone requirement. Its importance arises from the role terminology can play in whether instructions can be followed correctly and the device used safely.
French medical device localisation requires cross-document terminology review
Reviewing the French IFU without access to the French UI can leave this type of inconsistency undetected. The reverse is also true: a UI string may appear perfectly acceptable until it is compared with the terminology already established in the IFU.
French medical device localisation therefore benefits from reviewing terminology across the complete user journey rather than treating each file as an independent translation deliverable.
A regulatory-informed French medical device localisation specialist can identify terms that are accurate in isolation but inconsistent in context, check whether established terminology is being maintained across the IFU and UI, and flag differences that could affect the interpretation of an instruction.
The objective is not linguistic uniformity for its own sake. It is to ensure that when the French IFU tells a user what to do, the terminology on the device allows them to identify the corresponding action without ambiguity.
Could terminology inconsistencies in your French medical device content create a usability risk?
Contact Emi Lecret for specialist support with:
- French localisation
- Medical device translation
- UX writing for MedTech
- French Expert Reviews and Audits for MedTech & HealthTech User Interfaces
Emi Lecret
– Medical writer | translator | localization specialist | communication strategist for MedTech companies
Share
