Translating IFUs and Labelling as a Distributor: Requirements under the MDR

If you work in regulatory affairs for a medical device manufacturer, some of your distributors (or importers, if you are based outside the European Union) may be responsible for translating the instructions for use and labelling for their respective markets. They may also contribute to the translation process by reviewing or verifying the translation of the instructions for use and providing technical or terminological expertise.

In both cases, you need to determine how compliance of the information provided to the user is ensured. To do this, it is important to distinguish the distributor’s role, identify the applicable requirements and check the evidence available to support the process.

Distributor involvement does not remove the manufacturer’s obligations

This is an important point to understand: Article 10(11) of Regulation (EU) 2017/745 (MDR) places the responsibility on the manufacturer to provide the information described in Section 23 of Annex I in the language required by the relevant Member State. Outsourcing translations to the distributor does not remove this obligation.

The obligations of importers (Article 13) and distributors (Article 14) include checking that devices are accompanied by translated labelling and instructions for use. Furthermore, Question 18 of MDCG 2021-27 Rev. 1 also notes that outsourcing activities does not exempt them from their legal obligations. In conclusion, the manufacturer’s responsibilities remain in place alongside those of the other economic operators.

What happens if a user harmed by a defective translation brings a claim? The manufacturer is usually the first to be held liable, regardless of who carried out the translation. This liability falls under Directive 85/374/EEC rather than the MDR itself, as stated in Article 10(16) of the MDR.

It is worth noting that this directive will be repealed on 9 December 2026 by Directive (EU) 2024/2853. The latter will apply to products placed on the market or put into service after that date, while earlier products will remain subject to Directive 85/374/EEC.

The key point is that this liability cannot be limited by contract in relation to the injured party. As a manufacturer, however, you can define the distributor’s or importer’s responsibility in relation to translation in your agreement. This allows you to subsequently bring a claim against them.

What framework governs the translation process?

Article 16 of the MDR governs cases in which importers and distributors take on the manufacturer’s obligations when they make certain modifications to a device. Paragraph 2 clarifies that translating information supplied by the manufacturer does not, in itself, constitute a modification of the device. Furthermore, paragraphs 3 and 4 of the same article set out the requirements for distributors or importers who handle translation directly.

However, Section 2 of the MDCG 2021-26 guidance explains the key distinction regarding the role played by the distributor or importer in relation to translation. Article 16(2), (3) and (4) do not apply to subcontractors carrying out these activities on behalf of and under the control of the manufacturer, even if they are also distributors or importers.

If your company outsources translation to the distributor and retains control of the process, it should be treated as an outsourced activity of the manufacturer.

The situation changes when the distributor acts independently and provides the translation needed to make a device available on the market. In that case, you need to check whether their involvement falls within Article 16(2)(a).

What to check when Article 16 applies

When the distributor or importer carries out the translation independently, Article 16(3) and (4) set specific requirements for them:

• Identification of the activity performed and the operator responsible. In other words, if the translation is carried out by the distributor or importer, this must be indicated on the device, packaging or accompanying documentation.
• A quality management system to ensure that translations are accurate and up-to-date, preserve the device’s original condition and enable the implementation of corrective measures issued by the manufacturer.
• A certificate from a notified body designated for the type of devices concerned, confirming compliance with Article 16(3).
• Notification to the manufacturer and the competent authority at least 28 days before placing the device on the market with the translation. The certificate must also be submitted to the authority within that period.
• Availability of a sample with the translated labelling and instructions for use, if requested.

We recommend incorporating these points into the agreement with the distributor or importer and requesting the relevant supporting evidence. Article 16(4) does not grant the manufacturer prior approval rights over translations undertaken independently by the distributor. It simply requires the distributor to notify the manufacturer of the activity beforehand and supply a sample upon request.

You should also check the device’s regulatory status, specifically whether it is placed on the market under the MDR or as a legacy device. The MDCG 2021-26 guidance confirms that these requirements apply to Class I devices and that Article 16(3) and (4) do not apply to legacy devices.

The distributor as a reviewer: what they contribute and where their role ends

The distributor’s local knowledge can improve IFU translation, as well as labelling translation. At AbroadLink, we recommend drawing on this expertise as part of the translation process, with a clearly defined scope and verification of any proposed changes, provided this is feasible and practical for your company.

Involving distributors will complicate your QMS procedure and consume time and resources, so you should ensure that their involvement will add value to the translation process. Being a native speaker or having commercial knowledge of the device does not, in itself, demonstrate the competence required to review translations. In fact, you could consider a procedure whereby distributor involvement depends on the language concerned.

If you decide to involve the distributor, it is advisable to have a process for approving the person who will act as reviewer, taking into account factors such as their knowledge of the device, linguistic competence and educational background.

We also recommend verifying any changes proposed by the distributor before incorporating them into the translation. The linguist can check equivalence and consistency, while the manufacturer is responsible for resolving issues relating to technical matters, safety or intended purpose.

It is worth noting that Article 16 is the only MDR provision that explicitly states that translations must be accurate and up to date. This can be interpreted as setting the minimum standard required for all translations, whether performed by distributors or managed directly by the manufacturer.

Whether or not the legislator had this in mind is difficult to know. However, it is not uncommon for distributors to use their involvement in the process as an opportunity to adapt the instructions for use to their markets by adding or removing information, going beyond any additions that may be required under national legislation.

Regardless of whether such changes are justified, incorporating them into the translation would constitute a non-conformity. The resulting version would no longer correspond to the manufacturer’s information as required under Article 10(11) and Section 23 of Annex I, and the translation could no longer be considered “accurate”, even where the changes are entirely appropriate and improve the quality of the information provided to the user.

Practical tips for involving distributors or importers as experts in the translation process

If handled correctly, the involvement of the distributor or importer can provide valuable insight into the local market and end users. To ensure this knowledge improves the translation without compromising its accuracy or extending timelines, we recommend following a few guidelines:

• First, consider whether involving the distributor in the translation process is worthwhile: in practice, this may not be feasible or may offer no added value. This will depend on the on the specific distributor and your company’s negotiating power. It may not make sense at present, but it could be worth considering as an opportunity for improvement in the future.
• Involve them before translating. Ask them to validate the glossary of key terms related to the device before translation begins. This ensures their terminology preferences are addressed from the outset and makes subsequent review easier.
• Define in writing what they should review. Specify whether you expect them to check terminology, common usage in their market or end-user comprehension. Also clarify what they should not do, such as rewriting the text to suit stylistic preferences or correcting linguistic aspects.
• Appoint a single contact person for each language. Even if several people from the distributor are involved, designate one person to collate all their feedback. This helps prevent conflicting suggestions and terminology changes between versions.
• Provide the necessary context. Provide the original document alongside the translation, the approved glossary and a brief review guide explaining how to record comments.
• Agree on realistic deadlines. Set a deadline for receiving feedback and decide in advance how to proceed if it does not arrive on time. For example, continue with the version already validated by the translation provider.
• Centralise comments. Avoid receiving corrections by email or in separate PDFs. Using a shared review tool makes it easier to assess each suggestion and maintain the traceability required by the quality management system. In any case, standardise how changes are submitted.
• Keep corrections separate from content suggestions. If the distributor wants to add or remove information to adapt it to their market, the proposal should be referred to the manufacturer, who will decide whether to process it as a change to the original document through the change control process. Applying it only in the translation would constitute a non-conformity. The exception is where the change is required by law in the Member State in which the translation will be used.
• Apply the lessons learned. Transfer the approved changes to the glossary and translation memory so that they are applied to future versions and updates.

Conclusion

Distributor and importer involvement in translating IFUs and labelling can add significant value, but it does not transfer responsibility away from the manufacturer. The first step is to establish the applicable framework: if the distributor translates on its own initiative, the requirements of Article 16 apply; if it acts on behalf of and under the control of the manufacturer, translation is an outsourced activity that the manufacturer must manage within its quality management system.

Before choosing this approach, it is worth assessing whether it makes sense. A small manufacturer with a limited number of established distributors is unlikely to be a good candidate for implementing such a process, as the management burden may outweigh the benefits. In both cases, the key is the same: accurate, up-to-date translations backed by evidence, and any content changes validated by the manufacturer.

Finally, remember that AbroadLink is a medical and medical device translation company. We help manufacturers use their distributors’ knowledge within a controlled, traceable translation process.