How can you adapt instructions for use (IFUs) to a specific country while maintaining full MDR compliance in Europe?

Following on from our previous article on what it means to have accurate, up-to-date translations that are faithful to the master version, this article describes how to manage local adaptations without compromising compliance. At first glance, adapting instructions for use (IFUs) to a local market may appear to be nothing more than a simple language localisation task. However, under the MDR and IVDR regulations in Europe, any changes to the text can have a direct impact on regulatory compliance and may place liability on the manufacturer... or on the distributor.

A table published and regularly updated by the European Commission provides an overview of language requirements for each Member State.

IFUs are validated on the basis of the technical documentation approved by the notified body. When a local distributor amends a translation to “better align with the market”, they may go beyond simple adaptation, adding claims, changing indications or reformulating warnings. Under Article 16 of the MDR and IVDR, certain translation or repackaging activities performed by importers and distributors are strictly regulated and may, in some cases, subject them to the obligations of a manufacturer.

For PRRCs, QARA teams and medical device manufacturers, it is vital to understand how to localise an IFU without breaching regulatory requirements, all while maintaining full control of the validated content.

What MDR non-compliance risks can arise from local modifications to IFUs?

What may seem like a harmless request from a distributor (“we’ll simply reword it for the local market”) can in fact give rise to several risks:

• Discrepancies between the local IFU and the master IFU validated by the notified body.
• Inclusion or omission of safety information, such as warnings or contraindications.
• Changes to indications, intended use or performance claims.
• Translations that have not been updated after modifications to the technical documentation.

In practice, this can lead to:

• Non-compliance with MDR/IVDR if the local IFU no longer reflects the approved documentation.
• Inconsistencies between countries (e.g. France vs Germany) that are difficult to justify during an audit.
• Clinical risks: misinterpretation by healthcare professionals or patients.
• Reclassification of the distributor as a manufacturer if the modifications fall outside the scope of Article 16(2).

For example, a distributor who “clarifies” an indication to better align with local reimbursement rules may, unintentionally, broaden or restrict the intended use. This type of adjustment goes beyond simple translation and raises a compliance issue.

When does a local adaptation of a user manual become a regulatory amendment?

Article 16 of the MDR distinguishes between “permitted” translation/relabelling activities and modifications that place the operator in a quasi-manufacturing role.

Which adaptations remain within the scope of translation?

The following generally fall under language adaptation, provided that they are properly controlled and documented:

• Correction of grammar or terminology mistakes.
• Adaptation of wording to comply with standard usage in France, Spain or Germany.
• Revision of the names of organisations or local regulatory references.
• Compliance with the language requirements of certain Member States (e.g., the obligation to use French in France).

As long as the meaning, indications and warnings are identical to the master version, it can still be regarded as an accurate translation.

Which types of intervention constitute a change in content?

A regulatory change occurs when the distributor or any other party:

• Adds new clinical or marketing claims.
• Modifies the indications, contraindications or warnings.
• Changes the sequence or structure to the extent that certain warnings become less visible.
• Introduces non-validated information into the technical documentation.

In such cases, the operator may be subject to all or part of the manufacturer’s obligations under Article 16(1), including the implementation of a QMS, conformity assessment and, where applicable, the participation of a notified body.

What does Article 16 of the MDR and IVDR say about the translation of IFUs?

Article 16 of the MDR (and the equivalent article in the IVDR) provides the framework for:

• The translation of the information provided by the manufacturer, including IFUs.
• The changes to the outer packaging required for marketing in a Member State.
• The conditions under which these activities are not considered as a modification of the device.

Key points for PRRCs and QARA teams:

• Importers, distributors or other parties that translate IFUs must have an appropriate quality system in place for such activities.
• Translations must be accurate and up-to-date, which requires an update process aligned with the manufacturer.
• In certain cases (Article 16(4)), the operator must obtain a certificate from a notified body confirming that their relabelling or translation activities meet regulatory requirements.
• Document MDCG 2021-26 provides a detailed Q&A with examples of situations and recommended procedures.

For a manufacturer exporting to other countries, the challenge is to demonstrate that all localised IFU versions are controlled and that distributors operate within the established framework.

The importance of organising a controlled IFU localisation process between manufacturer and distributor

Defining the roles of the manufacturer, distributors and PRRC

To prevent uncoordinated actions, it is advisable to clearly define the following:

• The role of the manufacturer: owner of the master content, responsible for regulatory validation.
• The role of the PRRC: final validation of the compliance of localised IFUs.
• The role of distributors: “field” review (local terminology, user expectations) within a strict framework.
• The role of the specialised translation provider: guaranteeing linguistic quality and multilingual consistency.

A distribution agreement or global SOP may specify that any significant changes proposed by the distributor must be sent back to the manufacturer for documentary validation and may not be applied independently.

Best practices for localising IFUs

Below are some specific measures for a device sold in several European Union (EU) countries:

• Single master version: maintain a master IFU (generally in English) approved by the notified body.
• Validated translation memory and glossary for the main languages (French, German, Spanish, Italian, etc.).
• Formal workflow:
  • Translation by a service provider specialised in medical devices.
  • Local review (distributor) limited to commonly used terminology.
  • Final validation by the manufacturer’s QARA team/PRRC.
• Use of CAT (translation memory) tools to ensure consistency between versions and updates.
• Traceability: keep all versions, comments, decisions and justifications in the event of an audit.

During an audit or inspection, the PRRC must be able to demonstrate that the distributor’s role was limited to review and did not involve substantive changes, supported by documented traceability within the translation management system.

How can AbroadLink Translations help you ensure the compliance of your IFU translations?

A provider specialised in medical device translation like AbroadLink Translations can help you build a process that is compliant with Article 16:

• Team of medical translators trained in MDR/IVDR and device terminology.
• Creation of translation memories and glossaries specific to each manufacturer and range.
• Workflows that integrate local distributor reviews with comment management and track changes.
• Systematic quality controls (terminology checks, consistency, completeness).
• Possibility of producing version reports to support audits or exchanges with the notified body.

A typical case would involve an IFU approved for an implantable device sold in France and Germany: AbroadLink consolidates the master version, coordinates the translations, incorporates feedback from both markets, and ensures that the final text is strictly aligned with the validated indications and warnings.

Conclusion: how to maintain control over your localised IFUs

IFU localisation is no longer a mere linguistic exercise: it is a regulated process at the heart of the MDR and IVDR. Uncontrolled modifications by distributors may jeopardise your devices’ compliance and, at times inadvertently, place manufacturer responsibilities onto the distributor.

By structuring your process around a controlled master version, professional translation tools, a clear framework for distributors and a specialised partner, you can drastically reduce the risk of non-compliance and discrepancies during audits.

If you are a PRRC, QARA manager, or medical device manufacturer and you want to ensure the compliance of your multilingual IFUs in Europe, contact AbroadLink Translations to implement a fully traceable and sustainable localisation process.