Regulatory Affairs professionals operate under constant pressure from regulations such as the MDR and IVDR, which have turned documentation into a critical component of the medical product itself. The risk of non-compliance during an audit — and the regulatory, commercial and legal consequences that may follow — is a daily reality.
In this environment, attention often focuses on large-scale quality and compliance processes, under the assumption that the most significant risks lie there. In practice, however, some of the most serious vulnerabilities in document risk management arise from details that are often underestimated.
One of the most critical — and frequently overlooked — areas is the management of multilingual IFU and labelling translations. An error in the translation of the Instructions for Use (IFU) or product labelling is not merely a linguistic issue: it is a potential non-conformity that can directly affect patient safety and market access.
This article outlines seven common translation-related mistakes which, while seemingly minor, can become major issues during technical documentation reviews and audits — and ultimately undermine a company’s compliance strategy.
- Using ambiguous or incorrect terminology
Imprecise terminology is not simply a language issue; it is a critical error with direct implications for patient safety and risk classification.
A very common example when translating into English is the term sensible in French or Spanish. In many medical contexts, sensible refers to something that is sensitive or reactive (e.g. peau sensible, piel sensible).
However, translating it automatically as sensible in English is incorrect, as the English term refers to being reasonable or prudent, not physiologically sensitive. In product labelling or IFUs, this type of mistranslation can fundamentally alter the intended meaning and lead to misleading or even non-compliant claims.
From an audit perspective, this type of error directly impacts risk evaluation and would be closely scrutinised by a Notified Body during the review of the technical documentation. In regulated environments, poor terminology is not a minor flaw — it is a regulatory risk.
- Ignoring market-specific language requirements
One of the most basic — and costly — mistakes is failing to provide documentation in all required official languages.
Under the EU Medical Devices Regulation (MDR), documentation accompanying a medical product must be available in the official languages of the countries where it is placed on the market — which may mean up to 24 languages. In the UK, equivalent requirements apply under UK MDR and are enforced by the MHRA.
It is also important to remember that all legacy products must be fully MDR-compliant by the end of 2028, increasing pressure on effective multilingual documentation planning.
Missing a required language version is not a minor oversight. It is a direct regulatory non-compliance that may be classified as a major non-conformity and can result in restricted or blocked market access in a specific country.
- Relying on non-specialisedtranslation providers
Using generalist translation companies, freelance translators without regulatory experience, or workflows based on “machine translation plus internal review” is a common mistake in regulated industries.
In the medical products sector, a non-specialised provider is one that cannot demonstrate quality through objective, auditable standards. At a minimum, a qualified linguistic partner should hold:
- ISO 17100 certification (regulated translation process with mandatory second-linguist review)
- ISO 18587 certification (expert post-editing of machine translation)
Without these standards, the risk of terminological inaccuracies and regulatory misinterpretation increases significantly.
A provider unfamiliar with the requirements of bodies such as the EMA, the MHRA, or the nuances of the MDR is likely to deliver translations that are linguistically acceptable but regulatorily inadequate.
Under the MDR, multilingual documentation is an integral part of product conformity. A single mistranslated term in an IFU or on a label can lead to audit findings, market restrictions or even product withdrawal.
- Lacking robust version control for translated documentation
The absence of a robust version control system for translations is a serious quality management failure.
Throughout the lifecycle of a medical product, documentation is updated frequently. Without a process that combines professional translation tools (such as translation memories) with a stable team of linguists familiar with the product history, inconsistencies between language versions are almost inevitable.
If a safety warning is updated in English but not replicated consistently across all other languages, auditors will identify this as a document control failure — a core requirement under Article 10 of the MDR and ISO 13485. What starts as a minor observation can quickly escalate into a major non-conformity affecting the entire quality management system.
- Neglecting linguistic validation with end users
Assuming that a technically accurate translation is sufficient is a common misconception, particularly for patient-facing materials such as Clinical Outcome Assessments (COAs).
Linguistic validation ensures that translated instruments are understood consistently across different populations and cultural contexts, safeguarding the integrity of clinical data in multinational studies.
This process — including back translation and cognitive interviews with end users — is essential for both data quality and patient safety. Skipping linguistic validation may invalidate clinical data and be considered a critical audit deficiency, as it undermines two core compliance pillars: data reliability and patient safety.
- Incorrect adaptation of product claims
Product claims cannot be translated literally without considering local regulatory frameworks. A claim that is acceptable in one market may represent a compliance risk in another, triggering regulatory review.
This issue is particularly common in dermocosmetics, but it applies to all medical products and to all types of labelling and promotional material.
Poorly adapted claims may encourage off-label use, posing serious patient safety risks and exposing manufacturers to legal liability. Claim adaptation is not a marketing exercise — it is a critical component of regulatory risk management.
- Failing to providea declaration of translation accuracy
In many regulatory frameworks, authorities require a formal declaration confirming the accuracy and fidelity of translated documentation as part of registrations or variations.
Failing to provide this declaration constitutes a clear non-conformity that may call the validity of the entire submission into question. A specialised linguistic partner can manage these declarations correctly and, where required, provide additional certifications such as sworn or certified translations for legal or audit purposes.
Conclusion: translation as a compliance and risk management process
The issues outlined above are not simple language mistakes. They are genuine vulnerabilities in document risk management.
Multilingual IFU and labelling translation should not be treated as a cost centre, but as a critical compliance process and a key risk mitigation function. Underestimating it exposes organisations to audit findings, delayed product launches and potential market withdrawal.
Multilingual content management deserves the same level of rigour as any other core quality process. The key question is this: are your translation processes a strength within your compliance strategy — or could they become your Achilles’ heel at the next audit?
