Is it mandatory to use ISO 13485-certified translation providers under the MDR?

No. The MDR does not generally require medical device-related documentation to be translated by an ISO 13485-certified translation company.

Regulation (EU) 2017/745 on medical devices requires accompanying information to be available in the languages of the markets where the device will be placed on the market, while requiring manufacturers to maintain adequate control over their suppliers and processes. However, it does not require the company responsible for translating this documentation to hold ISO 13485 certification.

There is, however, a specific situation that can cause confusion: certain translations carried out by importers or distributors under Article 16 of the MDR must indeed be covered by a certified quality management system. This does not mean that the translation provider must be ISO 13485-certified.

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What the MDR actually requires for medical device translation

The MDR requires medical devices to be accompanied by the information necessary for their safe and proper use. Article 10 and Annex I establish, among other aspects, the requirements applicable to labelling and instructions for use.

In addition, this information must be provided in an official language of the Union determined by each Member State. The European Commission publishes a list of the language requirements applicable to medical devices in each country.

Therefore, when a manufacturer needs a translation of an IFU (instructions for use), a label or any other regulated documentation, it must ensure that the translation is accurate, consistent, up to date and understandable to the intended user.

In addition, each Member State may establish specific national language requirements for medical devices. In general, the information referred to in Section 23 of Annex I to the MDR must be provided in the language(s) required by the Member State where the device is made available or put into service. These requirements may therefore vary from one European country to another and should be checked against the applicable national legislation.

When does the MDR require a certified quality management system for a translation?

The main distinction can be found in Article 16 of the MDR.

When an importer or distributor translates information supplied by the manufacturer in order to place a device on the market in another Member State, it must have a quality management system in place to ensure, among other things, that the translation is accurate and up to date.

Furthermore, Article 16(4) stipulates that a notified body must certify that this system meets the requirements set out in Article 16(3). The European Commission has also published specific guidance, MDCG 2021-26, on the obligations of importers and distributors under Article 16.

This is the important distinction: in this specific case, the MDR requires a certified quality management system, but it does not require ISO 13485 certification or stipulate that the external translation company must be certified to this standard.

Therefore, it would not be correct to state as a general rule that “the MDR requires manufacturers to work with an ISO 13485-certified translation agency”.

So, what does ISO 13485 bring to a translation company?

ISO 13485 sets out requirements for quality management systems specifically related to the medical device industry.

Although the MDR does not generally require a translation company to hold this certification, working with a certified provider can facilitate the management of aspects such as:

• document and version control;
• project traceability;
• supplier management;
• handling of non-conformities;
• change management;
• record keeping;
• risk management;
• documented procedures.

These features can be particularly relevant when translating instructions for use, labelling, safety information or documentation that forms part of the regulatory file.

For this reason, when selecting medical device translation services, you should not focus solely on whether the provider holds a certificate. It is also worth checking how translators are selected, how content is reviewed, how terminology is controlled and what level of traceability the provider offers.

Does the manufacturer need to monitor the translation company?

Yes. This is probably the most relevant aspect from the manufacturer’s perspective.

Article 10(9) of the MDR requires the quality management system to include, among other elements, the selection and control of suppliers and sub-contractors. Therefore, if translation is outsourced, the manufacturer must evaluate the provider based on the importance and risk of the service provided.

ISO 13485 certification can simplify part of this evaluation, but it does not replace supplier control. The manufacturer remains responsible for defining the requirements, verifying that the process is appropriate and retaining the necessary evidence.

The European Commission provides information and guidance on the regulatory framework applicable to medical devices, as well as links to national competent authorities, which should be consulted alongside the MDR and other applicable national legislation.

When selecting a medical translation company, it is useful to look beyond its certifications and check whether it has specific processes in place for regulated documentation, traceability, terminology control and specialist review.

Conclusion: ISO 13485 is recommended, but not mandatory in all cases

So, is ISO 13485 certification mandatory for translating medical device documentation under the MDR? No, not as a general rule.

The MDR requires the quality of translations and the suppliers involved in regulated documentation to be controlled, but it does not automatically require manufacturers to use an ISO 13485-certified translation company.

The exception that often causes confusion is set out in Article 16: when certain importers or distributors translate information supplied by the manufacturer, they must have a certified quality management system in place. This does not mean that the language service provider is required to hold ISO 13485 certification.

Therefore, ISO 13485 certification can be an important advantage when demonstrating controlled processes, traceability and industry expertise, but it should be understood as a quality assurance measure rather than a universal requirement imposed by the MDR.