Multilingual documentation for medical devices: why is consistency between IFUs, website and marketing brochures essential for MDR compliance?

For a medical device manufacturer, the information provided to users is no longer delivered solely through IFUs. The same content, or content that is supposed to be the same, can be found on the website, in marketing brochures, in conference materials, in PDF files sent to distributors, and even on social media. As each team —marketing, digital, sales, regulatory— adds its own touch, consistency quickly becomes a challenge.

However, under Regulation (EU) 2017/745, all such materials together represent the manufacturer’s official information on the device. Whenever a website, brochure or campaign departs from the IFU and technical documentation, it is no longer just a matter of style or tone, but a potential non-compliance risk.

For PRRCs, QARA managers and manufacturers, it is therefore strategically important to consider all the content, documentation and translation of a medical device as an integrated system rather than as isolated files.

What are the most common inconsistencies between IFUs, websites and marketing materials?

In practice, discrepancies are rarely deliberate. They are mainly due to the fact that teams do not share a common reference or work within the same limitations. IFUs are structured, reviewed and validated. Websites and brochures, on the other hand, are often updated more quickly, in line with commercial needs.

This often leads to several recurring types of inconsistencies:

• “Expanded” indications and intended use on the website or in a marketing brochure compared to the IFU.
• Warnings and precautions that are shortened, simplified or even omitted from marketing materials.
• More ambitious performance claims in commercial content than in technical documentation.
• Inconsistent terminology: differing device name, accessories, users or conditions from one material to another.

When considered individually, these discrepancies may appear insignificant. However, when viewed as a whole, they build an image of the device that no longer fully corresponds to the version validated in the technical documentation and clinical file.

How can these discrepancies put MDR compliance at risk?

Article 7 of Regulation (EU) 2017/745 (MDR) is very clear regarding consistency between the various materials relating to a medical device. In fact, from labelling to advertising, the core message must essentially remain the same in order to avoid any divergence in communication.

In practical terms, these discrepancies can affect compliance at several levels:

• Intended use and indications
  • If the website presents broader indications for use than those stated in the IFU, the Notified Body may take the view that the manufacturer is promoting a non-assessed use.
  • A brochure suggesting new contexts of use may be interpreted as a change to the intended use that is not reflected in the technical documentation.
• Risk management and safety information
  • Truncated or missing warnings in the most widely used materials may undermine the evidence that the user is properly informed.
  • In the event of an incident, authorities will also examine the content of brochures and the website, not just the IFU.
• Post-market surveillance (PMS)
  • If the messages differ across materials, analysing field feedback becomes more difficult: some user behaviours were influenced by marketing, others by the IFU.
  • This can give the impression of a manufacturer that does not have full control over its communication and PMS.

Ultimately, the question is not whether a sentence “sounds better” on the website, but whether all communication remains consistent with regulatory requirements when taken as a whole.

How can multilingual documentation be approached as an interconnected system?

To regain control, it is helpful to shift from treating files independently to managing an editorial system, where each medium represents a different view of the same body of content.

The following elements can be found at the heart of this system:

• Structured technical documentation;
• A master IFU (often in English) that serves as a reference for intended use, indications, risks and warnings;
• A common foundation of validated content blocks, including intended use, benefits and key safety messages.

This core is then used to create the various different materials:

• Product pages on the website, downloadable technical datasheets, FAQs;
• Marketing brochures and leaflets;
• Training or presentation materials.

The basic rule is that all of these materials must reuse the same validated blocks, possibly adapting them in length or tone, but never altering them in a way that changes their meaning. When an update is required, following a vigilance action for example, the block is updated at the source and then propagated to all relevant materials, in all languages.

What best practices can be adopted to maintain this consistency across all languages?

Consistency does not rely on goodwill alone: it requires tools and procedures. Some measures have proven particularly effective for medical device manufacturers:

• Define a common regulatory and marketing glossary
  • Terms related to intended use, indications, users, risks and benefits.
  • Validation by QARA/PRRC teams and dissemination to all relevant teams (marketing, digital, agencies, etc.).
• Centralise content in translation memories
  • Use of CAT tools to store and reuse validated segments in all languages.
  • Automatic alignment between the IFU, website and brochures through the reuse of the same sentences.
• Establish an editorial validation workflow
  • Mandatory regulatory review for sensitive sections, such as indications, performance and warnings.
  • Systematic verification that all new text remains within the scope of the IFU and the technical documentation.
• Track updates
  • Version history by language and by material.
  • Documented links between technical or clinical changes and the corresponding text updates.

With this approach, consistency stops being a pipe dream and becomes an integral characteristic of the editorial system itself.

Why is a language service provider particularly well equipped to coordinate multilingual documentation?

A manufacturer often views content through separate channels: the regulatory team focuses on the IFU, marketing on brochures, and digital on the website. A language service provider, on the other hand, views everything as a whole: IFUs, labels, web content, brochures, product sheets, campaigns, and all of this across multiple languages.

This cross-functional perspective allows them to:

• Quickly identify message inconsistencies from one material to another;
• Suggest terminological or editorial harmonisation;
• Create and maintain translation memories and glossaries that are used across all channels;
• Organise workflows where each source update is automatically reflected in the relevant languages and materials.

In practice, a specialised partner like AbroadLink Translations can become the central coordinator of a manufacturer’s multilingual documentation, working in close collaboration with QARA teams, PRRCs, marketing teams and distributors to ensure that the message remains consistent, faithful to the file and up to date, in every language and across all materials.

For medical device manufacturers, the challenge goes far beyond language quality alone. It is about being able to demonstrate, in the event of an audit or inspection, that the company has full control over its communications regarding its products, across all channels and languages. This is precisely what a structured collaboration with a specialised translation company can provide.