MDR & IVDR: the importance of structuring translation processes

This article follows on from the one published on 29 January regarding the “ European Commission’s proposal for revising EU MDR and IVDR: Key points” (January 2026) and the effects that amending this proposal would have on the language aspect of the development of medical devices.

Translation processes for medical devices have now taken on strategic importance, going far beyond a simple linguistic step at the end of a project. Under MDR and IVDR, national authorities expect instructions for use, labelling, certain software interfaces and parts of the technical documentation to be provided in the official languages of the countries where the products are marketed.

Managing translation activities, as part of regulatory documentation support, is now seen as crucial to ensuring compliance. In this context, translation is a key stage in the document life cycle, which is carefully planned, controlled, documented and audited.

Furthermore, language requirements are regularly specified by both European and national authorities. Without a structured translation process, manufacturers —particularly SMEs— not only risk delays in placing products on the market, but also non-compliance issues during audits and inspections.

Implementing a formal, well-managed translation process has become a key driver of compliance, time-to-market and patient safety.

Why is “last-minute” translation no longer feasible under MDR and IVDR?

Translation was long treated as a last-stage task:

• Request made shortly before dossier submission or launch on a new market
• Files exchanged by email and tracked using spreadsheets
• Outsourcing without proper oversight or quality indicators

This system worked in the past, when regulatory requirements were less structured. Today, under MDR/IVDR, this exposes manufacturers to multiple risks:

• Inconsistencies between different language versions of the same document
• Unforeseen delays prior to an audit or a notified body inspection
• Difficulty in demonstrating who validated what, when and on which version

Poorly translated instructions for use or labels may be considered a non-conformity, rather than merely a “language issue”. In the absence of a structured translation process, these risks increase significantly as the document portfolio grows.

What do authorities and auditors actually expect in terms of language compliance?

Competent authorities and notified bodies no longer limit themselves to checking that “something has been translated”. They now closely examine how the process is managed and controlled.

What is an “integrated translation process”?

“Integrated translation process” refers to a formal, controlled process integrated within the quality system, recognised as a quality process in its own right.

Common audit questions include:

• How do you assess and approve your translation providers?
• How do you ensure terminological consistency across all languages?
• How are changes tracked, reviewed and approved?

Under MDR and IVDR, the following items must be available in the required languages:

• Labelling, IFUs and implant cards
• Declarations of conformity
• Field safety notices (FSN)
• Documents related to conformity assessment
• Software interfaces used by the user to operate the device

The guidelines also stress that translated IFUs must be faithful, accurate and reliable renditions of the original version (article 10 of the MDR), and that any discrepancies between language versions may be considered a compliance issue. A structured translation process documents each stage, from the initial request to final approval.

How can a structured translation process meet the new regulatory requirements?

A structured translation process goes beyond merely integrating a translation tool with your document management system. Translation should be integrated into your existing quality system and regulatory procedures. In practical terms, this means that translation is:

• Planned at the documentation drafting phase, not afterwards
• Structured around documented procedures, with clearly defined steps and responsibilities
• Aligned with processes for managing changes, versions and approvals

With this approach, translation becomes a defined, auditable process, rather than a succession of urgent, ill-planned projects.

For RA/QA and PRRC teams, the challenge is not to complicate the system, but to achieve greater:

• Control (who does what, when, and on which version)
• Planning (deadlines, costs, resources)
• Ability to demonstrate compliance during an audit, even for products across multiple languages and countries

How does a structured translation process work in practice?

Mature, experienced organisations generally recognise the importance of implementing such procedures, combining two mutually reinforcing concepts: anticipation and control. To this end, the following aspects must be taken into account:

• Language planning from the market launch strategy stage (e.g.: France and Germany in the first year, followed by expansion to Italy and the Nordic countries)
• Centralised terminology management, validated by medical, clinical and regulatory teams
• Defined control and validation steps, including, where applicable, review by local subsidiaries or distributors
• Full traceability between source content, translated versions, modifications and update dates
• Collaboration with qualified language partners operating under certified processes

In a typical scenario, the publication of a new English IFU version triggers:

1. Creation of translation batches into the relevant languages
2. Use of approved translation memories and glossaries
3. Specialised proofreading (medical/regulatory)
4. Formal approval and sign-off of all steps in the QMS

A structured translation process therefore helps to ensure that all multilingual versions are aligned, controlled and auditable, even several years later.

How does the complexity of the European market reinforce this need?

A launch is rarely limited to a single country. Each new market brings:

• Additional language combinations
• Specific national regulations
• Different document formats or channels (paper, electronic, eIFU)

Without a structured translation process, manufacturers quickly encounter:

• Terminological inconsistencies across countries and product lines
• Obsolete translations that are still in use in certain markets
• Delayed launches due to documents not being validated in all required languages on time

How can a structured translation process simplify audit preparation?

MDR/IVDR auditors are now placing greater focus on traceability. A structured translation process provides clear answers to questions such as:

• Who translated these instructions for use into French, German or Spanish?
• What terminology and regulatory references were used?
• When was the most recent update applied to all languages concerned?

A good system enables rapid production of:

• Version reports linking the source document and its translations
• Proof of the translation provider’s qualifications (certifications, audits, SLAs)
• Records of medical or regulatory proofreading, including local reviews

For ISO 13485 and ISO 9001 certified organisations, translation thus becomes a documented process — like design, production or vigilance— rather than a “blind spot” outside the QMS.

What role does a Life Sciences-specialised language partner play?

Integrating medical translation into the quality system does not require bringing all translators in-house. On the contrary, it generally involves working with a specialised translation company experienced in:

• MDR and IVDR requirements for medical devices and IVDs
• Constraints imposed by the quality system (ISO 13485, internal audits, CAPA)
• Practical expectations of notified bodies and national authorities

Such a partner must be able to:

• Implement translation processes that comply with translation standards, such as ISO 17100
• Manage translation memories and glossaries in coordination with in-house teams
• Adapt to your tools (PLM, QMS, CLM, document management systems) rather than the other way around
• Ensure full traceability and performance indicators for all languages

For RA/QA teams, this reduces the burden of operational oversight while maintaining overall responsibility for the structured translation process integrated into the quality system.

How can translation become a lever for compliance rather than a bottleneck?

Organisations that have implemented a structured translation process generally find:

• Fewer “last minute” issues prior to submission or audit
• Fewer non-conformities
• Greater consistency in documentation across different markets and product families
• Clear and demonstrable traceability
• Closer collaboration between Regulatory, Quality, Marketing and Operations teams

Conclusion

In settings where a translation error in an IFU or label can directly affect patient safety, translation becomes a key factor in compliance and risk management, not just a cost to reduce.

As a result, integrating a translation process into the quality system is no longer optional for ambitious manufacturers: it is a strategic choice for securing international growth.