What is meant exactly by “accurate” and “up-to-date” within the scope of the MDR 2017/745 language requirements for medical devices?

For medical device manufacturers, PRRCs and QARA teams, the requirements of Regulation (EU) 2017/745 (MDR) for IFUs, labelling and accompanying documentation go beyond simply “having the correct translation”. The Regulation stipulates that the information supplied by the manufacturer must be understandable, consistent and kept up-to-date in the languages required by each Member State.

The purpose of this article is to clarify these concepts and to propose practical ways of demonstrating, during an audit or inspection, that your IFU and label translations are genuinely “accurate” and “up-to-date” as required under MDR.

How does the MDR describe the information that must be supplied with the device?

First of all, it’s important to identify the documents in question and their types.

Annex I, Section 23 specifically stipulates that:

• The device must be accompanied by all the information necessary for its identification, safety and performance;
• This information must be easy to understand by the user or patient;
• If the manufacturer has a website, the relevant information must be made available and kept up-to-date.

Article 10(11) adds that this information must be provided in the official languages required by the Member State where the device will be placed on the market.

How can the terms “accurate” and “up-to-date” be interpreted by PRRCs?

Even though the terms “accurate” and “up-to-date” are not systematically used as such in the MDR, they describe the operational reality perfectly:

• Accurate = aligned with the validated master version (content, meaning, warnings, indications).
• Up-to-date = consistent with the latest approved version, including changes resulting from PMS, vigilance, CAPA, as well as modifications to the design or intended use.

In practice, for a PRRC or a QARA manager:

• “Accurate” means:

• The translation does not alter the intended use or indications;
• No warning is diluted, omitted or reformulated to the point of changing its meaning;
• No additional claims (related to performance or clinical benefit) are added locally.

• “Up-to-date” means:

• All languages reflect the same master version of the IFU;
• Changes resulting from PMS/vigilance/CAPA are propagated in all languages;
• No obsolete version is still in circulation in a given market.

Why are these requirements related to accurate and up-to-date translations central to MDR compliance?

What are the risks of an inaccurate translation?

An inaccurate translation can lead to:

• Regulatory risk

• Inconsistencies between the version submitted to the notified body and the translated version;
• Differences between countries (e.g. different wording of indications in French and German) that are difficult to justify during an audit;
• Application of article 16: certain actions by a distributor may subject them to the manufacturer’s obligations.

• Clinical risk

• Misinterpretation by healthcare professionals or patients;
• Use beyond the intended conditions if contraindications are not clearly indicated;
• Increase in incidents or near-incidents attributable to confusing information.

What are the risks of a translation that is not up-to-date?

A translation that is not up-to-date creates a gap between the regulatory reality and what the user sees:

• IFUs that do not reflect changes to the design or material;
• Failure to include a warning in response to a vigilance report;
• Coexistence on the market of old and new versions of the same IFUs.

In this case, the manufacturer may be considered in breach of their general obligations to keep documentation and information up-to-date.

Which articles of the MDR govern the translation and updating of information?

What are the key points of Article 10(11) and Annex I, Section 23?

For regulatory teams, there are three aspects that are particularly important:

• Article 10(11)

• The manufacturer must ensure that the device is accompanied by the information stipulated in Annex I, Section 23,
• in the official languages determined by each Member State.

• Annex I - Section 23: information supplied by the manufacturer

• Requirements for readability, clarity and consistency;
• Obligation to keep information up-to-date, particularly when the manufacturer has a website.

• Guidance on the Commission’s language requirements

• Summary table of language requirements by Member State;
• A reminder that the manufacturer must adapt to these requirements for each market.

How does Article 16 apply to translations carried out by distributors?

Article 16 specifies the situations in which the manufacturer’s obligations also apply to:

• Importers;
• Distributors;
• Other individuals involved in translating or repackaging devices.

In summary:

• A simple, accurate translation into the required language, performed under an appropriate quality system, can continue to be considered a standard economic operator activity;
• once chnages affect the content (addition or modification of information), this constitutes a regulatory change that could invoke the provisions of Article 16(1) and/or 16(4).

The MDCG 2021-26 Q&A outline specific cases of repackaging and relabelling, including translations.

Conclusion

In the context of translations for medical devices, the words “ accurate ” and “ up-to-date ” carry specific meaning and reflect a regulatory requirement under the MDR and IVDR regulations.

In practice, for a manufacturer, PRRC or QARA team, compliance with the MDR 2017/745 language requirements entails demonstrating that each IFU, label or other documentation is strictly aligned with the validated master version and is updated without delay whenever a change impacts the safety, performance or intended use of the device. In other words, being accurate and up-to-date are not just linguistic qualities: they are evidence of your quality system and risk management.

This is precisely where a specialised medical device and MDR translation service makes the difference: not only can it provide accurate translations, but it also understands the regulatory expectations for your documents and how to organise processes accordingly.