In the medical device industry, labelling is not merely a regulatory requirement, but a fundamental element in ensuring product safety, traceability and proper use. With the entry into force of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR), labelling has taken on an even more strategic role, particularly for companies operating across multiple European markets.
The information associated with a medical device, including labels, instructions for use (IFUs), symbols, warnings and technical content, must be accurate, legible and available in the languages required by each Member State. In this context, translation is no longer just a linguistic activity, but an integral part of regulatory compliance.
Terminology errors, inconsistencies between language versions or unclear instructions may have direct consequences on user safety and device compliance. For this reason, multilingual labelling management is now one of the main operational challenges for medical device manufacturers.
What Is Meant by Medical Device Labelling
To understand the role of translation in the medical sector, it is necessary to start from the definition of labelling.
Article 2(13) of Regulation (EU) 2017/745 MDR defines a “label” as any written, printed or graphic information appearing either on the device itself or on its packaging. However, the concept of labelling is much broader and includes all information supplied by the manufacturer concerning the identification, description, use and safety of the device.
Labelling therefore includes:
- labels affixed to the device
- primary and secondary packaging
- instructions for use (IFUs)
- warnings and precautions
- symbols and pictograms
- UDI information
- user documentation
- any electronic or digital information associated with the device
International IMDRF guidelines and the latest technical standards confirm an integrated approach to labelling, which includes labels, IFUs and all information supplied by the manufacturer regarding device identification, safety and use. This approach applies to medical devices regulated under MDR and IVDR, including in vitro diagnostic medical devices. An important reference is the IMDRF document “Principles of Labeling for Medical Devices and IVD Medical Devices”:
https://www.imdrf.org/sites/default/files/2024-04/IMDRF%20GRRP%20WG%20N52%20%28Edition%202%29.pdf
Why Labelling Is a Critical Element of MDR Compliance
The MDR assigns a central role to labelling in device risk management and safety. Information must be easily understandable for the intended user and enable the product to be used correctly and safely.
This means that labelling does not have a purely descriptive function, but directly contributes to the device’s regulatory compliance. IFUs and labels are examined during notified body audits, MDR certification processes, technical compliance assessments and post-market surveillance activities. Inconsistent or outdated documentation may lead to non-conformities, delays in market access or requests for regulatory review.
The management of symbols is also becoming increasingly important. The MDR encourages the use of harmonised and standardised symbols to improve understanding and international consistency.
Labelling Translation: A Regulatory Responsibility
Within the MDR framework, translating labelling does not simply mean converting a text from one language into another. It means ensuring that all information associated with the device maintains technical accuracy, clarity and regulatory consistency in every target market.
Each Member State may require labels and IFUs to be available in its official language. This obliges medical companies to manage multiple synchronised language versions.
The most common issues involve inconsistent terminology between IFUs and labels, overly literal translations, discrepancies between technical documentation and labelling, failure to update all language versions simultaneously and loss of readability after desktop publishing.
In the medical sector, even the smallest ambiguity may compromise the correct interpretation of instructions for use and increase operational risk.
For this reason, labelling translation must be managed through controlled and specialised processes.
IFUs and Readability: The Role of Plain Language
One of the most delicate aspects concerns the readability of instructions for use (IFUs). IFUs must contain complete technical and regulatory information while remaining easily understandable for the intended user.
This issue is particularly important for patient-facing devices, home-use products and devices used in highly critical clinical environments.
Excessively long sentences, inconsistent terminology or overly technical linguistic structures may reduce understanding of the instructions.
For this reason, more and more companies are adopting plain language principles even within regulatory documentation, improving clarity of instructions, readability of warnings and accessibility of information.
Linguistic quality therefore concerns not only grammatical correctness, but directly impacts the safety and effectiveness of medical communication.
Best Practices for Medical Labelling Translation
Effective multilingual labelling management requires structured workflows and shared processes involving regulatory affairs, quality assurance and linguistic teams.
Companies operating in the medical sector increasingly adopt centralised terminology glossaries, specialist reviews and multi-level quality controls to maintain consistency across IFUs, labels, software and technical documentation.
Revision management is also essential. Every regulatory or technical update must be implemented simultaneously across all target languages, avoiding misalignments that could affect compliance.
Another often underestimated aspect concerns desktop publishing. Final readability also depends on the correct graphical management of symbols, spacing and information hierarchies.
Companies adopting structured linguistic processes generally succeed in reducing review times, operational costs and regulatory issues.
Multilingual Labelling Management: The Main Challenges
Complexity increases in international projects involving multiple European markets and frequent documentation updates.
Every technical modification to the device may require simultaneous updates of IFUs, labels, packaging, technical datasheets, software UI and regulatory declarations.
Without centralised coordination, the risk of inconsistencies between language versions grows rapidly.
For this reason, many medical companies are investing in translation management systems, shared terminology databases and collaborative workflows. The goal is not only to translate faster, but to ensure documentation continuity and compliance throughout the entire device lifecycle.
A Practical Example of MDR-Compliant Labelling Management
In a recent MDR project, Aglatech14 supported an Italian company specialised in infection control solutions in the multilingual management of documentation associated with professional sterilisation systems.
The project involved the translation of IFUs and technical documentation into 22 European languages, with particular attention to terminology consistency across labelling, manuals and regulatory updates.
To ensure consistency and control, a dedicated team was established consisting of project managers, linguists specialised in the medical sector, quality specialists and technology specialists. The use of shared glossaries and centralised review systems made it possible to keep all language versions aligned even during changes introduced throughout the project.
This type of approach enables medical companies to manage complex multilingual labelling projects while reducing the risk of inconsistencies and simplifying international compliance management.
Conclusions
In the medical device sector, labelling is now a strategic element of MDR compliance. Labels, IFUs and all information associated with the device are not merely regulatory documents, but essential tools for ensuring safety, traceability and correct product use.
In an increasingly multilingual European market, labelling translation therefore plays a central role. Terminological accuracy, readability and coordination of language versions become essential factors in avoiding non-conformities and ensuring operational continuity.
For medical companies, investing in structured linguistic management processes means improving documentation quality, reducing regulatory risk and addressing more efficiently the complexity introduced by the MDR.
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